89976 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

1See Medicare Program: Clinical Laboratory 

Improvement amendments of 1988 (CLIA) Fees; 83 

FR 67723; https://www.federalregister.gov/ 

documents/2018/12/31/2018-28359/medicareprogram-clinical-laboratory-improvementamendments-of-1988-clia-fees. 

2https://www.federalregister.gov/documents/ 

2022/07/26/2022-15300/clinical-laboratoryimprovement-amendments-of-1988-clia-feeshistocompatibility-personnel-and. The public 

comment period was extended and closed on 

September 26, 2022 (87 FR 52712). https://

www.federalregister.gov/documents/2022/08/29/ 

2022-18558/clinical-laboratory-improvementamendments-of-1988-clia-fees-histocompatibilitypersonnel-and. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 493 

[CMS–3326–F] 

RIN 0938–AT47 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) Fees; 

Histocompatibility, Personnel, and 

Alternative Sanctions for Certificate of 

Waiver Laboratories 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS) and Centers 

for Disease Control and Prevention 

(CDC), Department of Health and 

Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: This final rule updates the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) fees and 

clarifies the CLIA fee regulations. This 

final rule implements a process for 

sustainable funding for the CLIA 

program through a biennial two-part 

increase of CLIA fees. We are finalizing 

the incorporation of limited/specific 

laboratory fees, including fees for 

follow-up surveys, substantiated 

complaint surveys, and revised 

certificates. We are also finalizing the 

distribution of the administrative 

overhead costs of test complexity 

determination for waived tests and test 

systems with a nominal increase in 

Certificate of Waiver (CoW) fees. In 

addition, we are finalizing the 

clarification of the methodology used to 

determine program compliance fees. 

This final rule ensures the continuing 

quality and safety of laboratory testing 

for the public. This final rule also 

amends histocompatibility and 

personnel regulations under CLIA to 

address obsolete regulations and update 

the regulations to incorporate 

technological changes. In addition, this 

final rule amends the provisions 

governing alternative sanctions 

(including civil money penalties, a 

directed plan of correction, a directed 

portion of a plan of correction, and 

onsite State monitoring) to allow for the 

imposition of such sanctions on CoW 

laboratories. 

DATES: These regulations are effective 

January 27, 2024, except for instruction 

3, amending § 493.2; instructions 14 

through 19, amending §§ 493.945, 

493.1273, 493.1274, 493.1278, 493.1359, 

and 493.1405; instruction 20 removing 

§ 493.1406; instructions 21 through 30,

amending §§ 493.1407, 493.1411,

493.1417, 493.1423, 493.1443, 493.1445, 

493.1449, 493.1451, 493.1455, and 

493.1461; instruction 31 removing 

§ 493.1462; and instructions 32 through

36, amending §§ 493.1463, 493.1469,

493.1483, 493.1483, 493.1489, and

493.1491, which are effective December

28, 2024.

FOR FURTHER INFORMATION CONTACT:

Penny Keller, CMS, (410) 786–2035; or

Heather Stang, CDC, (404) 498–2769.

SUPPLEMENTARY INFORMATION:

Executive Summary 

A. Purpose

This final rule clarifies and updates

CLIA regulations that protect the health 

and safety of laboratory consumers and 

address the financial stability of the 

CLIA program. Specifically, the final 

rule: (1) adjusts laboratory fees to 

provide sustainable funding for the 

user-fee-funded CLIA program; (2) 

revises certain requirements for both the 

histocompatibility test specialty as well 

as personnel qualifications and 

responsibilities for CLIA laboratories; 

and (3) provides additional discretion to 

CMS by allowing it to impose 

alternative sanctions against noncompliant Certificate of Waiver 

laboratories, rather than being limited 

only to imposing principal sanctions of 

revocation, suspension or limitation of a 

laboratory’s CLIA certificate. 

B. Summary of the Major Provisions

1. Clinical Laboratory Improvement

Amendments of 1988 (CLIA) Fees

On October 31, 1988, Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578), which revised 

in its entirety section 353 of the Public 

Health Service Act (PHSA). Section 

353(m) of the PHSA requires the 

Secretary to impose two separate types 

of fees: ‘‘certificate fees’’ and 

‘‘additional fees.’’ Certificate fees are 

imposed for the issuance and renewal of 

certificates and must be sufficient to 

cover the general costs of administering 

the CLIA program, including evaluating 

and monitoring approved proficiency 

testing (PT) programs and accrediting 

bodies and implementing and 

monitoring compliance with program 

requirements. Additional fees are 

imposed for inspections of 

nonaccredited laboratories and for the 

cost of evaluating accredited 

laboratories to determine overall if an 

accreditation organization’s standards 

and inspection process are equivalent to 

the CLIA program. These evaluations 

are referred to as validation inspections. 

The additional fees must be sufficient to 

cover, among other things, the cost of 

carrying out such inspections. 

Certificate and additional fees vary by 

group or classification of laboratory, 

based on such considerations as the 

Secretary determines relevant, which 

may include the total test volume and 

scope of the testing being performed by 

the laboratories, and only a nominal fee 

may be required for the issuance and 

renewal of Certificates of Waiver 

(CoWs). 

We issued a notice with comment 

period in the December 31, 2018 

Federal Register (83 FR 67723 through 

67728) 1 (hereinafter referred to as the 

December 31, 2018 notice). The 

December 31, 2018 notice increased fees 

for laboratories certified under CLIA. 

The December 31, 2018 notice increased 

CLIA fees by 20 percent to help ensure 

the CLIA program could continue to be 

self-sustaining, as required by law. The 

2018 increase was intended to give CMS 

time to propose a process through 

rulemaking to allow for ongoing changes 

to the CLIA fees. Despite that increase, 

the level of carryover funding available 

to cover program expenses is projected 

to decline continuously. As such, the 

CLIA program will not be selfsupporting by the end of FY 2023 

without an additional fee increase. The 

changes finalized in this rule will result 

in a continuous level of funding that 

increases as the obligations to the CLIA 

program increase and keep the program 

adequately funded over time. 

On July 7, 2022, we published a 

proposed rule (87 FR 44896) 2

(hereinafter referred to as the July 2022 

proposed rule) that would make changes 

to the methodology for determining the 

amount of the CLIA fees as described in 

the February 28, 1992 final rule with 

comment period (57 FR 7002) 

(hereinafter referred to as the February 

1992 final rule) and codified in 42 CFR 

part 493, subpart F—General 

Administration. The fees for the CoW, 

Certificate for Provider-performed 

Microscopy (PPM) Procedures, and the 

provisional certificate that we refer to as 

the Certificate of Registration (CoR) 

were based on the cost of issuing the 


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Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 89977 

certificates. The Certificate of 

Accreditation (CoA) and Certificate of 

Compliance (CoC) fees were based on 

the annual test volume and scope of 

testing that separated the laboratories 

into schedules or groups of laboratories. 

We generally proposed, and are 

finalizing in this rule, to continue 

basing these fees on either the costs of 

issuing the certificates (CoW, CoR, and 

PPM) or annual test volume and scope 

of testing (CoA and CoC). However, we 

are now including in this final rule 

additional government costs that were 

not accounted for in the calculation 

method outlined in the February 1992 

final rule. As one such change, we 

proposed to allocate, directly from the 

CoW fees, the administrative overhead 

costs of the Food and Drug 

Administration (FDA) process to 

categorize clinical laboratory tests as 

waived as described in the 

memorandum of understanding (MOU) 

between CMS and FDA (IA19–23). In 

addition, we proposed to implement 

certificate fees for the issuance of 

replacement and revised certificates. 

Thousands of replacement and revised 

certificates are generated and mailed 

annually. We believe this additional 

certificate fee will encourage 

laboratories to better manage their 

certificates, provide accurate 

information when applying for or 

updating a CLIA certificate, and cover 

the costs of producing duplicate or 

revised documents. 

The February 1992 final rule also 

stated at § 493.645(b)(1) that laboratories 

issued a CoA would be assessed a fee to 

cover the cost of evaluating the 

individual laboratories to determine 

whether an accreditation program’s 

standards and inspection policies are 

equivalent to the Federal program. We 

proposed at the new § 493.645(a)(1) to 

clarify that all accredited laboratories 

share in the validation inspections cost. 

Under § 493.645(b)(1), the accredited 

laboratories currently pay a fee even 

though HHS inspects only 5 percent of 

them annually. The fee is 5 percent of 

what the inspection cost of an 

equivalent nonaccredited CoC 

laboratory would pay based on the test 

volume and scope (that is, the schedule 

or group) of the laboratories. 

In the February 1992 final rule, the 

inspection fees for laboratories holding 

a CoC were based on estimates of the 

length of time required to perform a 

laboratory survey in the different 

schedules multiplied by the estimated 

hourly rate of three different entities, 

the State agency, contracted surveyors, 

and Federal surveyors, that perform 

surveys. Of these three entities, an 

hourly rate was established solely for 

the State agencies, as any contracted 

surveyors’ salaries are paid by their 

contractual amount. The Federal 

surveyors perform their surveys in 

conjunction with non-survey work plus 

actual costs for travel to those surveys. 

Given this diversity of costs, it is not 

feasible to determine a Federal hourly 

rate for just the survey activities. In the 

July 2022 proposed rule, we proposed to 

cease using the hourly rate outlined in 

current regulations as the basis for 

determining compliance inspection fees 

for laboratories holding a CoC and 

replace it with the methodology 

proposed in the proposed rule, and 

which we are finalizing in this final 

rule. We proposed to keep inspection 

fees separated by the schedules as 

previously determined. 

The additional fees allowed for in 

section 353(m) of the PHSA are fees for 

determining compliance with the CLIA 

regulations. Some of these fees were 

previously included in subpart F but 

were not implemented due to technical 

limitations. However, we stated in the 

proposed rule that a new data system 

that can implement these requirements 

is under development. Therefore, as 

discussed further in this final rule, we 

are finalizing the implementation of 

additional fees as outlined in the 

February 1992 final rule, to be effective 

30 days after the publication of the final 

rule, although collection may not begin 

until the new data system is 

implemented. We believe the collection 

of these additional fees will help bridge 

the shortfall between program 

expenditures and collections as 

discussed in section I.A.1.a. of this final 

rule. 

The February 1992 final rule 

provisions codified at 42 CFR part 493, 

subpart F—General Administration 

were numbered too close together to 

allow new provisions or the separation 

of existing provisions, for clarification, 

to stay in numerical order. Therefore, 

we proposed to redesignate and 

renumber some provisions so that the 

flow of this section is easier to follow. 

For example, we proposed to 

redesignate current § 493.646 as new 

§ 493.655 to maintain thematic order in 

that § 493.655, which outlines the 

payment of fees, is better placed after 

the provisions discussing the different 

types of fees. Each such change, 

including this example, is explained in 

full at its designated provision within 

section II. of this final rule. 

Upon the final rule effective date, 

which will be 30 days following 

publication, we proposed implementing 

fee increases as described previously in 

this rule. Using the more recent data 

available for this final rule, we expect 

the fee increase to be larger than 

subsequent fee increases. The fee 

increase includes an across-the-board 

increase of 18 percent and an inflation 

factor (CPI–U) of 1.049598. We utilized 

the CPI–U factors promulgated by OMB 

as part of their economic assumptions 

for budgetary estimates. To calculate the 

4.9598 percent compound factor for the 

2-year increase, we multiplied together 

factors for each of the 2 years as follows: 

• Factor Year 1 (Budgeted Rate for 

Fiscal Year (FY) 2024) = 1.026 

• Factor Year 2 (Budgeted Rate for FY 

2025) = 1.023 

The compounded factor = 1.026 × 

1.023 = 1.049598. 

The 18 percent across-the-board 

(ATB) increase was determined as the 

amount that, including newly charged 

fees and inflation, is the difference 

necessary to fund total annual projected 

program obligations and allow for the 

gradual accumulation of 6 months’ 

worth of obligations as an operating 

margin at the start of the year. We have 

calculated that the one-time 18 percent 

across-the-board increase would 

generate approximately 12.1 million 

dollars annually while the inflation 

factor would generate approximately 4.6 

million dollars. Based on the more 

recent data available for this final rule, 

the other proposed fees would generate 

approximately 7.7 million dollars for a 

total of approximately 24.4 million 

dollars per year. 

We believe this will stabilize the CLIA 

program and allow us to use the 

inflation factor for future biennial 

increases. Should future across-theboard percentages be required, CMS will 

calculate them as stated in § 493.680(a). 

The revised certificate fee found at 

proposed § 493.639(a); the replacement 

certificate fee found at proposed 

§ 493.639(b); the fees for the follow-up 

surveys, substantiated complaint 

surveys, and unsuccessful PT on CoC 

laboratories found at proposed 

§ 493.643(d)(1) through (4); follow-up 

surveys on CoA laboratories found at 

proposed § 493.645(a)(2); and 

substantiated complaint surveys on 

CoW, PPM, or CoA laboratories found at 

proposed § 493.645(b) will be 

implemented on the effective date of the 

final rule. However, the collection of the 

fees is dependent on the new data 

system being online. 

This final rule finalizes the proposed 

CLIA fee provisions with the 

modifications described in section II of 

this final rule. 

2. CLIA Requirements for 

Histocompatibility 

The CLIA regulations include 

requirements specific to certain 


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89978 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

3https://www.cdc.gov/cliac/docs/summary/ 

cliac1114_summary.pdf. 

4https://www.federalregister.gov/documents/ 

2022/07/26/2022-15300/clinical-laboratoryimprovement-amendments-of-1988-clia-feeshistocompatibility-personnel-and. 

laboratory specialties such as 

microbiology and subspecialties such as 

endocrinology. Histocompatibility is a 

type of laboratory testing performed on 

the tissue of different individuals to 

determine if one person can accept 

cells, tissue, or organs from another 

person. The CLIA regulatory 

requirements for the specialty of 

histocompatibility at § 493.1278, 

including the crossmatching 

requirements, address laboratory testing 

associated with organ transplantation 

and transfusion and testing on 

prospective donors and recipients. As of 

January 2023, 247 CLIA-certified 

laboratories perform testing in this 

specialty. The specialty of 

histocompatibility has not been updated 

since the February 1992 final rule (57 

FR 7002). Many of the changes finalized 

in this rule will remove 

histocompatibility-specific requirements 

from § 493.1278 that we have 

determined are addressed by the general 

QC requirements at §§ 493.1230 through 

493.1256 and 493.1281 through 

493.1299. We believe that removing 

specific requirements for obsolete 

methods and practices and eliminating 

redundant requirements will decrease 

the burden on laboratories performing 

histocompatibility testing. We have 

heard from interested parties, 

particularly the transplantation 

community, that physical crossmatches 

are a barrier to modernized decisionmaking approaches on organ 

acceptability based on risk assessment. 

For the crossmatching regulations that 

this final rule will amend, HHS 

requested input from the Clinical 

Laboratory Improvement Advisory 

Committee (CLIAC) on the acceptability 

and application of newer crossmatching 

techniques in lieu of physical 

crossmatching. At its November 2014 

meeting, CLIAC made the following 

recommendations 3 for CMS to explore: 

• Regulatory changes or guidance(s)

that would allow virtual crossmatching 

to replace physical crossmatching as a 

pre-requisite for organ transplant. 

• Appropriate criteria and decision

algorithms, based on CLIAC’s 

deliberation of the Virtual Crossmatch 

Workgroup’s input, under which virtual 

crossmatching would be an appropriate 

substitute for physical crossmatching. 

The determination of appropriate 

criteria and decision algorithms should 

involve a process that includes an open 

comment period. 

In the 2018 RFI (83 FR 1005 through 

1006, 1008), we requested comments 

and information related to 

histocompatibility and crossmatching 

requirements that may have become 

outdated and requested suggestions for 

updating these requirements to align 

with current laboratory practice. The 

comments we received in response to 

the 2018 RFI recommended updating 

the current histocompatibility and 

crossmatching requirements to align 

with current laboratory practices. The 

CLIAC recommendations and the 

comments from the 2018 RFI informed 

the changes that we proposed in the July 

2022 proposed rule, and which we are 

finalizing in this final rule. 

This final rule finalizes the proposed 

histocompatibility provisions of the 

proposed rule with the modifications 

described in section III.A. of this final 

rule. 

3. CLIA Requirements for Personnel

The CLIA regulations related to

personnel requirements were updated 

with minor changes to the doctoral high 

complexity LD qualifications in the 

2003 final rule (68 FR 3713, Jan. 24, 

2003), but otherwise have remained 

unchanged since we published the 

February 1992 final rule with comment 

period (57 FR 7002). In the 2018 RFI (83 

FR 1005 through 1006, 1008), we sought 

public comment and information related 

to CLIA personnel requirements in the 

following areas: nursing degrees; 

physical science degrees; personnel 

competency assessment (CA); personnel 

training and experience; and nontraditional degrees. These are areas that 

the CDC, CMS, interested parties, and 

State agency surveyors identified as 

relevant to our efforts to update the 

CLIA personnel requirements to better 

reflect current knowledge, changes in 

the academic context, and 

advancements in laboratory testing. 

In response to our questions about 

nursing degrees, the majority of 

commenters did not concur that nursing 

degrees were equivalent to a biological 

or chemical sciences degree. However, 

some interested parties suggested 

nursing degrees could be used as a 

separate qualifying degree for 

nonwaived testing personnel (TP). In 

response to our questions about 

physical science degrees as well as nontraditional degrees, interested parties 

commented that a physical science 

degree was hard to define. In 

considering how to evaluate physical 

science and other non-traditional 

degrees, some commenters 

recommended that we evaluate 

coursework taken using a semester-hour 

educational algorithm to qualify 

individuals for CLIA personnel 

positions. In response to the questions 

about competency assessment (CA), 

many commenters stated that 

individuals with an applicable associate 

degree should be permitted to perform 

CA on moderate complexity TP. Some 

commenters stated that required 

training should depend on the 

complexity of the testing to be 

performed and that all nonwaived 

testing should require training related to 

the individual’s laboratory 

responsibilities. Several commenters 

also stated that any required training 

and experience should be in a CLIAcertified laboratory. Many commenters 

agreed that all training and experience 

should be documented; many noted that 

documentation from a former employer 

should be acceptable, assuming it 

provided specific details about the 

individual’s job, training, and CA. 

We also requested input from CLIAC 

for recommended changes to the CLIA 

personnel requirements found in 

subpart M—Personnel for Nonwaived 

Testing, §§ 493.1351 through 493.1495. 

CLIAC made 12 recommendations at the 

April 2019 meeting to improve CLIA 

personnel regulations, including: (1) 

making biological science degrees 

acceptable for laboratory personnel and 

considering candidates with other 

degree backgrounds based on 

coursework; (2) removing the degree in 

physical science from the CLIA 

regulations due to its broadness; and (3) 

requiring personnel to have training and 

experience in their areas of 

responsibility. Following this, CMS and 

CDC collaborated to develop a list of 

personnel regulation updates that we 

proposed in the July 2022 proposed 

rule.4

We are finalizing the proposed 

provisions for personnel with the 

modifications described in section III.B. 

in this final rule. 

4. Alternative Sanctions for CoW

Laboratories

As discussed in section III.C. of the 

proposed rule and this final rule, we 

proposed, and are finalizing, an 

amendment to § 493.1804(c)(1) to allow 

CMS to impose alternative sanctions on 

CoW laboratories, as appropriate. CoW 

laboratories are laboratories that only 

perform waived tests, that is, simple 

laboratory examinations and procedures 

that have an insignificant risk of an 

erroneous result. For example, a urine 

dipstick pregnancy test is a waived test. 

The current regulations state that we do 

not impose alternative sanctions on 

CoW laboratories because those 


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Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 89979 

laboratories are not inspected for 

compliance with condition-level 

requirements (§ 493.1804(c)(1)). 

However, while not subject to the 

biennial routine surveys, CoW 

laboratories are surveyed as a result of 

a complaint, and based on the 

complaint survey, may be found to be 

out of compliance with a conditionlevel requirement. In the absence of 

alternative sanctions, our only recourse 

in cases of compliance issues found at 

CoW laboratories is to apply principal 

sanctions (that is, revocation, 

suspension, or limitation of the CLIA 

certificate). We believe the ability to 

levy alternative sanctions (that is, civil 

money penalties, a directed plan of 

correction, a directed portion of a plan 

of correction, and onsite State 

monitoring) on CoW laboratories helps 

CMS ensure appropriate sanctions are 

applied to CoW laboratories, as in the 

case of other certificate types (certificate 

of PPM, CoR, CoC, CoA). 

In addition, we believe that this 

finalized change will reduce burden on 

CoW laboratories. The ability to impose 

alternative sanctions will be particularly 

useful in instances in which we find 

proficiency testing (PT) referral 

violations. PT is the testing of unknown 

samples sent to a laboratory by an HHSapproved PT program to check the 

laboratory’s ability to determine the 

correct testing results. This final rule 

amends the CoW regulations at 

§ 493.1804(c)(1) to allow for the 

application of alternative sanctions 

where warranted, in addition to or in 

lieu of principal sanctions. 

We are finalizing the provisions for 

alternative sanctions for CoW 

laboratories as described in section III.C. 

in this final rule. 

C. Summary of Costs and Benefits 

BILLING CODE 4120–01–P 


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89980 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

BILLING CODE 4120–01–C 

I. Background 

A. Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) Fees 

On October 31, 1988, Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578), which revised 

in its entirety section 353 of the Public 

Health Service Act (PHSA). Section 

353(m) of the PHSA requires the 

Secretary to impose two separate types 

of fees: ‘‘certificate fees’’ and 

‘‘additional fees.’’ Certificate fees are 

imposed for the issuance and renewal of 

certificates and must be sufficient to 

cover the general costs of administering 

the CLIA program, including evaluating 

and monitoring approved proficiency 

testing (PT) programs and accrediting 

bodies and implementing and 

monitoring compliance with program 

requirements. Additional fees are 

imposed for inspections of 

nonaccredited laboratories and for the 

cost of evaluating accredited 

laboratories to determine overall if an 

accreditation organization’s standards 

and inspection process are equivalent to 

the CLIA program. These evaluations 

are referred to as validation inspections. 

The additional fees must be sufficient to 


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TABLE 1: Costs and Benefits 

Provision Description Total Impact/Costs 

CLIA Fee Regulations for CLIA We estimate that the overall impact of updating the CLIA fees would be 

laboratories an increase of$24,371,183. The fmal rule impacts approximately 298,791 

CLIA certified laboratories: Certificate of Waiver (CoW) = 235,175; 

Certificate for Provider-performed Microscopy (PPM) Procedures = 

29,717; Certificate of Registration (CoR) = 2,891; Certificate of 

Compliance (CoC) = 17,694; Certificate of Accreditation (CoA) = 15,935. 

(Data from Casper 85s 02/07/2022). 

Although the effect of the changes will increase laboratory costs, 

implementation of these changes would be negligible in terms of workload 

for laboratories as these fee increases are operational and technical in 

nature and do not require additional time to be spent by laboratory 

employees. 

Histocompatibility and Personnel We estimate that the overall impact of adding requirements for the 

Regulations for CLIA laboratories changes in personnel, histocompatibility, and travel for LD on-site visits 

would range from $20,894,051 to $30,520,189 in the first year. The 

estimated costs included: (1) Laboratories updating policies and 

procedures related to personnel and histocompatibility, (2) Accrediting 

organizations and exempt States updating policies and procedures related 

to personnel, histocompatibility, and laboratory director site visit, (3) 

Travel for site visits-Driving, and 4) Travel for site visits-Flying. 

We estimate that the cost to laboratories, accrediting organizations, and 

exempt States to comply with the changes in the fmal rule would range 

between $20,894,051 and $30,520,189 in 2023 dollars for the first year 

and between $628,437 and $1,659,134 in subsequent years. Although the 

requirements will increase laboratory costs, the implementation of the fmal 

rule will streamline and simplify regulations, add flexibility in laboratory 

hiring practices, ensure that the LD is on-site at least twice per year, and 

align histocompatibility testing with current methods and practices. 

Alternative Sanction We believe this fmal rule will increase flexibility, decrease potential 

burden while moving those laboratories toward compliance, and have no 

added economic impact on Co W laboratories. 

As previously described, this regulatory change could decrease the burden 

for sanctions imposed for improper proficiency testing referral. Although 

we have no data indicating that principal sanctions have been imposed on 

Co W laboratories for this reason in the past, if it occurred in the future, the 

ability to impose alternative sanctions, if appropriate, would be less 

punitive and potentially decrease any quantifiable economic impact. At 

this time, we cannot quantify what that impact would be. 
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 89981 

5https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Index. 

6https://www.federalregister.gov/documents/ 

2022/07/26/2022-15300/clinical-laboratoryimprovement-amendments-of-1988-clia-feeshistocompatibility-personnel-and. The public 

comment period was extended and closed on 

September 26, 2022 (87 FR 52712). https://

www.federalregister.gov/documents/2022/08/29/ 

2022-18558/clinical-laboratory-improvementamendments-of-1988-clia-fees-histocompatibilitypersonnel-and. 

cover, among other things, the cost of 

carrying out such inspections. 

Certificate and additional fees vary by 

group or classification of laboratory, 

based on such considerations as the 

Secretary determines relevant, which 

may include the total test volume and 

scope of the testing being performed by 

the laboratories, and only a nominal fee 

may be required for the issuance and 

renewal of Certificates of Waiver 

(CoWs). 

In January 2018, we published the 

‘‘Request for Information: Revisions to 

Personnel Regulations, Proficiency 

Testing Referral, Histocompatibility 

Regulations and Fee Regulations under 

the Clinical Laboratory Improvement 

Amendments (CLIA) of 1988’’ (83 FR 

1004). As part of the general solicitation 

for comments related to the CLIA fees, 

more than a few commenters noted that 

the CLIA compliance and additional 

fees have not been updated since 1997 

and supported increasing the fees. Some 

of these commenters suggested that the 

CLIA fees be reviewed annually and 

updated as needed to cover the program 

costs of performing surveys. 

Based on comments from the public 

on the Request for Information (RFI), we 

issued a notice with comment period in 

the December 31, 2018 Federal Register 

(83 FR 67723 through 67728) 

(hereinafter referred to as the December 

31, 2018 notice). The December 31, 2018 

notice increased fees for laboratories 

certified under CLIA. The December 31, 

2018 notice increased CLIA fees by 20 

percent to help ensure the CLIA 

program could continue to be selfsustaining, as required by law. The 2018 

increase was intended to give CMS time 

to propose a process through 

rulemaking to allow for ongoing changes 

to the CLIA fees. The changes finalized 

in this rule will result in a continuous 

level of funding that increases as the 

obligations to the CLIA program 

increase and keep the program 

adequately funded over time. 

In September 2020, we released new 

tools to reduce burdensome paperwork 

and authorization delays for laboratories 

seeking CLIA certification. Laboratories 

now have the option to pay CLIA 

certification fees on the CMS CLIA 

program website. Online payments are 

processed overnight, which is 

substantially faster than hard-copy 

checks.5

In July 2022, we published a proposed 

rule (87 FR 44896) 6 (hereinafter referred 

to as the July 2022 proposed rule) that 

would make changes to the 

methodology for determining the 

amount of the CLIA fees as described in 

the February 28, 1992 final rule with 

comment period (57 FR 7002) 

(hereinafter referred to as the February 

1992 final rule) and codified in 42 CFR 

part 493, subpart F—General 

Administration. The fees for the CoW, 

Certificate for Provider-performed 

Microscopy (PPM) Procedures, and the 

provisional certificate that we refer to as 

the Certificate of Registration (CoR) 

were based on the cost of issuing the 

certificates. The Certificate of 

Accreditation (CoA) and Certificate of 

Compliance (CoC) fees were based on 

the annual test volume and scope of 

testing that separated the laboratories 

into schedules or groups of laboratories. 

We generally proposed, and are 

finalizing in this rule, to continue 

basing these fees on either the costs of 

issuing the certificates (CoW, CoR, and 

PPM) or annual test volume and scope 

of testing (CoA and CoC). However, as 

described below, we are now including 

additional government costs that were 

not accounted for in the calculation 

method outlined in the February 1992 

final rule. 

As one such change, we proposed to 

allocate, directly from the CoW fees, the 

administrative overhead costs of the 

Food and Drug Administration (FDA) 

process to categorize clinical laboratory 

tests as waived as described in the 

memorandum of understanding (MOU) 

between CMS and FDA (IA19–23). We 

believe this is appropriate because the 

functions of the FDA under the MOU 

are to provide administrative support to 

the CLIA program, such as by 

categorizing tests as waived. 

In addition, we proposed to 

implement certificate fees for the 

issuance of replacement and revised 

certificates. We receive numerous 

requests daily for replacements of lost 

and misplaced certificates and for 

revised copies of certificates after 

demographic, laboratory director (LD), 

and/or specialty/subspecialty changes. 

As a result, thousands of replacement 

and revised certificates have been 

generated and mailed annually. We 

believe this additional certificate fee 

will encourage laboratories to better 

manage their certificates, provide 

accurate information when applying for 

or updating a CLIA certificate, and cover 

the costs of producing duplicate or 

revised documents. 

The February 1992 final rule also 

stated at § 493.645(b)(1) that laboratories 

issued a CoA would be assessed a fee to 

cover the cost of evaluating the 

individual laboratories to determine 

whether an accreditation program’s 

standards and inspection policies are 

equivalent to the Federal program. The 

February 1992 final rule explained that 

there would be a random sample of 5 

percent of all accredited laboratories 

inspected by the Department of Health 

& Human Services (HHS), and the 

findings compared to the findings of the 

Accreditation Organizations (AOs). The 

February 1992 final rule stated that all 

accredited laboratories would share the 

cost of this activity and that the fees 

would be the same as for inspections by 

nonaccredited laboratories. We 

proposed new § 493.645(a)(1) to clarify 

that all accredited laboratories share in 

the validation inspections cost. Under 

§ 493.645(b)(1), the accredited

laboratories currently pay a fee even

though HHS inspects only 5 percent of

them annually. The fee is 5 percent of

what the inspection cost of an

equivalent nonaccredited CoC

laboratory would pay based on the test

volume and scope (that is, the schedule

or group) of the laboratories.

In the February 1992 final rule, the 

inspection fees for laboratories holding 

a CoC were based on estimates of the 

length of time required to perform a 

laboratory survey in the different 

schedules multiplied by the estimated 

hourly rate of three different entities 

that perform surveys. As outlined in the 

February 1992 final rule, we believe this 

methodology was a starting point 

intended to allow the methodology to be 

adjusted as historical data and 

experience were gained. The three 

inspection entities mentioned in the 

February 1992 final rule were the State 

agency, contracted surveyors, and 

Federal surveyors. Of these three 

entities, an hourly rate was established 

solely for the State agencies, as any 

contracted surveyors’ salaries are paid 

by their contractual amount. The 

Federal surveyors perform their surveys 

in conjunction with non-survey work 

plus actual costs for travel to those 

surveys. Given this diversity of costs, it 

is not feasible to determine a Federal 

hourly rate for just the survey activities. 

Due to these difficulties, in July 2022 

we proposed to cease using the hourly 

rate outlined in current regulations as 

the basis for determining compliance 

inspection fees for laboratories holding 

a CoC and replace it with the 

methodology proposed in the proposed 

rule, and which we are finalizing in this 


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89982 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

final rule. We proposed to keep 

inspection fees separated by the 

schedules as previously determined. 

The additional fees allowed for in 

section 353(m) of the PHSA are fees for 

determining compliance with the CLIA 

regulations. Some of these fees were 

previously included in subpart F but 

were not implemented due to technical 

limitations. However, we stated in the 

proposed rule that a new data system 

that can implement these requirements 

is under development. While initially 

targeted for completion in October 2022, 

the new data system remains under 

development. Therefore, as discussed 

further in this final rule, we are 

finalizing the implementation of 

additional fees as outlined in the 

February 1992 final rule, to be effective 

30 days after the publication of the final 

rule, although collection may not begin 

until the new data system is 

implemented. We believe the collection 

of these additional fees will help bridge 

the shortfall between program 

expenditures and collections as 

discussed in section I.A.1.a. of this final 

rule. 

The February 1992 final rule 

provisions codified at 42 CFR part 493, 

subpart F—General Administration 

were numbered too close together to 

allow new provisions or the separation 

of existing provisions, for clarification, 

to stay in numerical order. Therefore, 

we proposed to redesignate and 

renumber some provisions so that the 

flow of this section is easier to follow. 

For example, we proposed to 

redesignate current § 493.645(a) as 

§ 493.649(a) and remove the current 

regulatory text at § 493.649. In addition, 

we proposed redesignating current 

§ 493.646 as new § 493.655 to maintain 

thematic order in that § 493.655, which 

outlines the payment of fees, is better 

placed after the provisions discussing 

the different types of fees. Each such 

change, including this example, is 

explained in full at its designated 

provision within section II. of this final 

rule. 

Upon the final rule effective date, 

which will be 30 days following 

publication, we proposed implementing 

fee increases as described previously in 

this rule. Using the more recent data 

available for this final rule, we expect 

the fee increase to be larger than 

subsequent fee increases. The fee 

increase includes an across-the-board 

increase of 18 percent and an inflation 

factor (CPI–U) of 1.049598. We utilized 

the CPI–U factors promulgated by OMB 

as part of their economic assumptions 

for budgetary estimates. To calculate the 

4.9598 percent compound factor for the 

2-year increase, we multiplied together 

factors for each of the 2 years as follows: 

• Factor Year 1 (Budgeted Rate for 

Fiscal Year (FY) 2024) = 1.026 

• Factor Year 2 (Budgeted Rate for FY 

2025) = 1.023 

The compounded factor = 1.026 × 

1.023 = 1.049598. 

The 18 percent across-the-board 

(ATB) increase was determined as the 

amount that, including newly charged 

fees and inflation, is the difference 

necessary to fund total annual projected 

program obligations and allow for the 

gradual accumulation of 6 months’ 

worth of obligations as an operating 

margin at the start of the year. We have 

calculated that the one-time 18 percent 

across-the-board increase would 

generate approximately 12.1 million 

dollars annually while the inflation 

factor would generate approximately 4.6 

million dollars. Based on the more 

recent data available for this final rule, 

the other proposed fees would generate 

approximately 7.7 million dollars for a 

total of approximately 24.4 million 

dollars per year. These projections are 

summarized in Table 2. 

We believe this will stabilize the CLIA 

program and allow us to use the 

inflation factor for future biennial 

increases. Should future across-theboard percentages be required, CMS will 

calculate them as stated in § 493.680(a). 

The revised certificate fee found at 

proposed § 493.639(a); the replacement 

certificate fee found at proposed 

§ 493.639(b); fees for the follow-up 

surveys, substantiated complaint 

surveys, and unsuccessful PT on CoC 

laboratories found at proposed 

§ 493.643(d)(1) through (4); follow-up 

surveys on CoA laboratories found at 

proposed § 493.645(a)(2); and 

substantiated complaint surveys on 

CoW, PPM, or CoA laboratories found at 

proposed § 493.645(b) will be 

implemented on the effective date of the 

final rule. However, the collection of the 

fees is dependent on the new data 

system being online. 

1. CLIA Budget Process 

In the proposed rule, Table 1 

provided a summary of projected user 

fee collections, program obligations, and 

carryover balances from FY 2021 

through the end of FY 2025. In Table 3 

of this final rule, we have expanded the 

information as presented in Table 1 of 

the proposed rule to include actual 

figures for FYs 2019 through 2022 

which show the effect the 20 percent 

increase in 2019 had on CLIA’s finances 

and updated projections for FYs 2023 

through FY 2026 reflecting updated 

estimates of program spending, user fee 

collections, carryover, and inflation. 

Table 3 does not include any proposed 

or finalized fee increases. We are also 

including additional detail related to 

total CLIA obligations. Start of year 

carryover balances plus anticipated 

collections at current rates, net of 

sequester, equals budgetary resources 

available for obligation, or spending, in 

a given fiscal year. This amount, less 

projected program obligations, equals 

end-of-year carryover. The continued 

decrease in the projected end-of-year 

carryover shows that despite the 2019 

increase, financial obligations for the 

CLIA program continue to significantly 

outpace user fee collections at current 

rates. This final rule will create 

sustainable funding in a few different 

ways. 

BILLING CODE 4120–01–P 


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TABLE 2: Projected FY 2024 Collections With the Fee Increases Implemented in this Final 

Rule 

FY 2024 Post Final Rule 

Across the Board $12.1 million 

Inflation Factor (1.049) $4.60 million 

Other Fees $7.7 million 

Total $24.4 million 

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TABLE 3: CMS Actual and Projected CLIA Obligations and Fee Collections Without Finalized Fe

FY 2019 FY2020 FY 2021 Actual FY 2022 Actual FY2023 FY2024 F

Actual Actual 

Available $35,801,852 $37,828,689 $37,971,994 $35,606,303 $36,705,507 $26,066,877 $

Carryover (SOY)* 

New collections $60,154,865 $63,969,709 $70,009,410 $72,694,131 $70,019,000 $70,019,000 $

Sequester ($3,729,602) ($3,774,213) ($3,990,536) ($4,143,565) ($3,991,096) ($3,991,096) (

Available 

Budgetary $92,227,115 $98,024,185 $103,990,868 $104,156,869 $102,733,631 $92,095,002 $

Resources** 

State Survey Costs $21,672,324 $21,958,788 $22,988,860 $26,184,632 $28,726,380 $29,473,266 $

Other Operations $24,407,020 $20,936,453 $29,418,719 $26,082,439 $26,745,981 $27,441,377 $

Costs 

Administration $18,149,927 $18,682,234 $19,619,008 $19,619,008 $21,194,393 $21,745,447 $

Costs 

Total $64,229,272 $61,577,475 $72,026,587 $71,765,273 $76,666,754 $78,660,090 $

Obligations*** Carryover (BOY)* $27,997,843 $36,446,710 $31,964,280 $32,391,596 $26,066,877 $13,434,912 ($

*SOY= Start of Year; EOY = End of Year. SOY carryover amounts in fiscal years 2019 through 2022 include the effects of prior yearadjustmen

* * Budgetary resources mean amounts available to be obligated. In this instance, it means the sum of available carryover + new user fee collec

reductions. 

*** Obligations as of fiscal year end. The figure for Total Obligations is the sum of State Survey Costs, Other Operations Costs and Costs of A
89984 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

a. Two-Part Periodic Increase 

As we explained in the July 2022 

proposed rule, establishing a two-part 

periodic increase could be easily 

implemented and would provide an 

understandable calculation of fee 

increases. CMS will publish future fee 

increases in a notice in the Federal 

Register. CMS will not publish a notice 

in the Federal Register if no fee 

increases are required. Every 2 years, in 

preparation for the biennial fee increase, 

we will calculate the inflation 

adjustment using the Consumer Price 

Index for all Urban Consumers (CPI–U). 

At that time, CMS will look back over 

the previous 2 years and determine if 

the calculated CPI–U inflation 

adjustment will be sufficient to cover 

actual program obligations. If the total 

fee amounts, including any increase 

applied, do not match or exceed actual 

program obligations based on a review 

of the obligations of the previous 2 

years, CMS will apply an additional 

across-the-board increase to each 

laboratory’s fees by calculating the 

difference between the total fee amounts 

and actual program obligations. If CMS 

determines that the inflation adjustment 

is not enough to cover the program 

obligations, an additional across-theboard amount will be added to the 

adjustment to ensure that the fee 

increase is spread equally across all fees 

in a flat percentage amount, which will 

cover CLIA obligations. The adjusted 

fees will become part of the baseline for 

the next biennial increase. If the level of 

collections was found to be sufficient to 

cover program obligations, CMS will not 

implement a biennial inflation 

adjustment or an across-the-board fee 

increase. With any fee increase, the 

amount of the increase and a summary 

of CLIA obligations along with the 

calculations of the increase using the 

CPI–U and any determined shortfall will 

be published in a notice in the Federal 

Register. 

Table 4 shows a representation of the 

change in national average laboratory 

fees for the two-part increase of 4.9598 

percent over the current fees with a onetime 18 percent across the board 

increase at the time of implementation. 


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TABLE 4: Examples, Two-part Increase per Certificate Type * 

National Average CoC compliance fee/CoA Validation Survey fee 

Laboratory Current average Example, One-Time 18% 

classification Across the board with 

(schedule) Biennial Increase of 4.96% 

CoC CoA CoC CoA 

LVA** $360 $18 $446 $22 

A $1,192 $60 $1,477 $74 

B $1,591 $80 $1,970 $98 

C $1,988 $99 $2,463 $123 

D $2,336 $117 $2,894 $145 

E $2,684 $134 $3,325 $166 

F $3,032 $152 $3,755 $188 

G $3,380 $169 $4,187 $209 

H $3,728 $186 $4,618 $231 

I $4,076 $204 $5,049 $252 

J $4,408 $220 $5,459 $273 

Not aoolicable - - - -

*Note: The Certificate of Registration (CoR) fee would increase from the $150 to $184. 

**LVA "Schedule A, Low Volume". 

***CoW $248 includes $223 + $25 CoW one-time increase. 

CLIA Biennial Certificate f

Current average Example, One

with Bie

CoC/CoA CoW PPM CoC/CoA 

$180 - - $223 

$180 - - $223 

$180 - - $223 

$516 - - $639 $528 - - $654 $780 - - $966 

$1,320 - - $1,635 

$1,860 - - $2,304 $2,448 - - $3,032 $7,464 - - $9,244 

$9,528 - - $11,801 

- $180 $240 - 
89986 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

b. Collection of Other Authorized Fees 

The CLIA regulations also authorize 

the collection of other fees; however, the 

program has historically not exercised 

its authority in collecting these fees due 

to technical difficulties. With the 

improvement in technology since 1992, 

we will be enforcing existing regulatory 

authority in the collection of these fees 

as well as clarifying circumstances 

when such fees are applicable. This 

final rule will implement collection of 

these other fees, which are laboratory 

specific and provide an incentive for 

laboratories to remain compliant with 

all provisions of the CLIA regulations. 

The fees include: 

• A fee for follow-up surveys to 

determine correction of the deficient 

practices found in either a CoC survey 

or a CoA validation survey; 

• An addition of a specialties survey 

fee when it is necessary to determine 

compliance of testing in one or more 

additional specialties outside of the CoC 

survey cycle; 

• A substantiated complaint survey 

fee; 

• A fee for a desk review of 

unsuccessful PT performance; 

• A fee for a replacement certificate 

when a laboratory loses or destroys a 

CLIA certificate and requests a 

replacement certificate; and 

• A fee for issuing a revised 

certificate when the laboratory changes 

the laboratory director or other 

information found on a certificate and 

requests a new certificate to reflect the 

changes. 

Table 5 projects the national average 

fees per incident. These fees were 

previously authorized in the February 

1992 final rule but were not collected. 

We are now finalizing the collection of 

these additional fees. We totaled the 

number of follow-up surveys, 

substantiated complaints, and 

unsuccessful PT events and multiplied 

them by the national average number of 

hours recorded by the State survey 

agencies for these activities in FY2019. 

For follow-up surveys, substantiated 

complaints, and unsuccessful PT events 

we then multiplied that by the national 

average unit cost, which is $108.78 in 

FY2023. The amounts for the revised 

certificates and replacement certificates 

are the fee amount as discussed in 

section II.C. of this final rule, 

specifically at § 493.639(a). 

BILLING CODE 4120–01–C 

2. CoW Fee Increase 

This final rule authorizes a fee 

increase for the CoW. A CoW laboratory 

is limited to performing tests 

categorized by FDA as waived, which 

are simple laboratory examinations and 

procedures that have an insignificant 

risk of an erroneous result, including 

those that employ methodologies that 

are so simple and accurate as to render 

the likelihood of erroneous results by 

the user negligible, or that the Secretary 

has determined pose no unreasonable 

risk of harm to the patient even if 

performed incorrectly. Some examples 

of waived tests include fingerstick tests 

for blood glucose or cholesterol. As part 

of our financial obligations to 

administer the CLIA program, we 

compensate FDA for its role in 

determining if tests and test systems 

meet criteria to be categorized as waived 

tests/test systems. This final rule 

implements a nominal increase for CoW 

fees which will offset program 

obligations to FDA for its role under the 

CMS–FDA MOU (IA19–23) in 

categorizing tests and test systems as 

waived. The obligation to CLIA, defined 

by the MOU and calculated against the 

number of CoW laboratories, is 

approximately $25 per laboratory to 

cover the FDA obligation. The 

additional $25.00 will increase the 

current $180.00 biennial CoW fee to 

$205.00. 

B. CLIA Requirements for 

Histocompatibility, Personnel, and 

Alternative Sanctions for CoW 

Laboratories 

CLIA requires any laboratory that 

examines human specimens for the 

purpose of providing information for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of health, of human beings 

to be certified by the Secretary for the 

categories of examinations or 

procedures performed by the laboratory. 

The implementing regulations at 42 CFR 

part 493 specify the conditions and 

standards that must be met to achieve 

and maintain CLIA certification. These 

conditions and standards strengthen 

Federal oversight of clinical laboratories 


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TABLE 5: Projection of other Authorized Fees per Certificate Type 

Projected National Average Other Authorized fees 

Follow-up surveys Unsuccessful 

(including those for Substantiated Proficiency 

the addition of Complaint Testing (PT) Replacement Revised 

Certificate type specialties) Surveys event Certificates Certificates 

Certificate of Compliance $497 $2836 $780 $75 $150 (CoC) 

Certificate of $497 $7564 $780 $75 $95 Accreditation (CoA) 

Certificate of Registration $497 $4230 $780 $75 $150 (CoR) 

Certificate of Waiver n/a $2059 n/a $75 $95 (CoW) 

Certificate for Providerperformed Microscopy n/a $3858 n/a $75 $150 

(PPM) Procedures 
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 89987 

7See the ‘‘Medicare, Medicaid and CLIA 

Programs; Regulations Implementing the Clinical 

Laboratory Improvement Amendments of 1988 

(CLIA)’’ final rule with comment period (57 FR 

7002) that published in the February 28, 1992 

Federal Register (hereinafter referred to as the 

‘‘1992 final rule with comment period’’). 

8See the ‘‘Medicare, Medicaid, and CLIA 

Programs; Laboratory Requirements Relating to 

Quality Systems and Certain Personnel 

Qualifications’’ final rule (68 FR 3640) that 

published in the January 24, 2003 Federal Register 

(hereinafter referred to as the ‘‘2003 final rule’’). 

9See the 1992 final rule with comment period. 

10See the ‘‘Request for Information: Revisions to 

Personnel Regulations, Proficiency Testing Referral, 

Histocompatibility Regulations and Fee Regulations 

Under the Clinical Laboratory Improvement 

Amendments of 1988 (CLIA)’’ RFI (83 FR 1004) that 

published in the January 9, 2018 Federal Register 

(hereinafter referred to as the ‘‘2018 RFI’’). 

11https://www.cdc.gov/cliac/docs/summary/ 

cliac1114_summary.pdf. 

and help ensure the accuracy and 

reliability of patient test results. 

CMS is always looking for ways to 

improve our programs and better serve 

our beneficiaries. Concerning laboratory 

oversight, HHS endeavors to improve 

consistency in the application of 

laboratory standards, coordination, 

collaboration, and communication in 

both routine and emergent situations, 

thereby further improving laboratory 

oversight and, ultimately, patient care. 

The regulations related to CLIA 

histocompatibility and personnel 

requirements have not been updated 

since 1992 7 and 2003,8 and the 

regulations for CoW laboratory 

alternative sanctions have not been 

updated since 1992.9 HHS believes it is 

time to update these regulations to 

reflect the current state of the American 

health care system and new advances in 

technology. 

HHS sought expert advice to inform 

our decision-making on the regulatory 

updates finalized in this rule. We 

solicited advice on several topics 

addressed in this rule from the Clinical 

Laboratory Improvement Advisory 

Committee (CLIAC), the official Federal 

advisory committee charged with 

advising HHS regarding appropriate 

regulatory standards for ensuring 

accuracy, reliability, and timeliness of 

laboratory testing. On January 9, 2018, 

we also issued a Request for 

Information 10 (RFI) that solicited input 

from the public on issues related to 

CLIA personnel and histocompatibility 

requirements, and alternative sanctions 

for CoW laboratories. We received 

approximately 8,700 total comments in 

response to the 2018 RFI. The CLIAC 

recommendations and information 

received in response to the 2018 RFI 

helped us determine the policies that 

were proposed in the July 2022 

proposed rule, for which we received 

20,574 public comments. We considered 

the public comments received in 

determining the policies finalized in 

this final rule. 

This final rule amends 

histocompatibility and personnel 

regulations to address obsolete 

regulations and update the regulations 

to incorporate changes in technology. 

This final rule also amends 

§ 493.1804(c) to allow alternative 

sanctions to be imposed on CoW 

laboratories. We summarize and 

respond to the public comments on 

these proposals and summarize our final 

policies in section III of this final rule. 

1. Histocompatibility 

The CLIA regulations include 

requirements specific to certain 

laboratory specialties such as 

microbiology and subspecialties such as 

endocrinology. Histocompatibility is a 

type of laboratory testing performed on 

the tissue of different individuals to 

determine if one person can accept 

cells, tissue, or organs from another 

person. The CLIA regulatory 

requirements for the specialty of 

histocompatibility at § 493.1278, 

including the crossmatching 

requirements, address laboratory testing 

associated with organ transplantation 

and transfusion and testing on 

prospective donors and recipients. As of 

January 2023, 247 CLIA-certified 

laboratories perform testing in this 

specialty. The current specialty 

regulations were published in the 1992 

final rule with comment period, and 

additional changes were made in the 

2003 final rule. Specifically, the 2003 

final rule changed the regulations to 

decrease the number of specialty/ 

subspecialty-specific quality control 

(QC) regulations in instances where 

general QC requirements would apply. 

The specialty of histocompatibility has 

not yet been similarly updated. Many of 

the changes finalized in this rule will 

remove histocompatibility-specific 

requirements from § 493.1278 that we 

have determined are addressed by the 

general QC requirements at §§ 493.1230 

through 493.1256 and 493.1281 through 

493.1299. We believe that removing 

specific requirements for obsolete 

methods and practices and eliminating 

redundant requirements will decrease 

the burden on laboratories performing 

histocompatibility testing. We have 

heard from interested parties, 

particularly the transplantation 

community, that physical crossmatches 

are a barrier to modernized decisionmaking approaches on organ 

acceptability based on risk assessment. 

For the crossmatching regulations that 

this final rule will amend, HHS 

requested input from CLIAC on the 

acceptability and application of newer 

crossmatching techniques in lieu of 

physical crossmatching. The CLIAC 

gathered information on the 

acceptability and application of newer 

crossmatching techniques for 

transplantation because there have been 

advances in the field of transplantation 

since 1992. These advances have made 

the physical crossmatch less significant 

in non-sensitized patients. The CLIAC 

stated that histocompatibility testing has 

advanced in technology overtime, from 

using cell-based assays to complex 

testing procedures such as molecular 

typing and solid-phase platforms for 

antibody detection, with improved 

accuracy and sensitivity. Significant 

changes have occurred in the clinical 

practice of transplantation 

(immunosuppression, desensitization 

practices), and improvements in antirejection therapies have led to improved 

outcomes and mitigation of risk due to 

human leukocyte antigen (HLA) 

antibodies. At its November 2014 

meeting, CLIAC made the following 

recommendations 11 for CMS to explore: 

• Regulatory changes or guidance(s) 

that would allow virtual crossmatching 

to replace physical crossmatching as a 

pre-requisite for organ transplant. 

• Appropriate criteria and decision 

algorithms, based on CLIAC deliberation 

of the Virtual Crossmatch Workgroup’s 

input, under which virtual 

crossmatching would be an appropriate 

substitute for physical crossmatching. 

The determination of appropriate 

criteria and decision algorithms should 

involve a process that includes an open 

comment period. 

In the 2018 RFI (83 FR 1005 through 

1006, 1008), we requested comments 

and information related to 

histocompatibility and crossmatching 

requirements that may have become 

outdated and requested suggestions for 

updating these requirements to align 

with current laboratory practice. The 

comments we received in response to 

the 2018 RFI recommended updating 

the current histocompatibility and 

crossmatching requirements to align 

with current laboratory practices. The 

CLIAC recommendations and the 

comments from the 2018 RFI informed 

the changes that we proposed in the July 

2022 proposed rule, and which we are 

finalizing in this final rule, after 

consideration of comments received. 

2. Personnel 

The CLIA regulations related to 

personnel requirements were updated 

with minor changes to the doctoral high 

complexity LD qualifications in the 


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89988 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

12https://www.cdc.gov/cliac/docs/summary/ 

cliac0419_summary.pdf. 

13https://www.federalregister.gov/documents/ 

2022/07/26/2022-15300/clinical-laboratoryimprovement-amendments-of-1988-clia-feeshistocompatibility-personnel-and. 

2003 final rule (68 FR 3713) but 

otherwise have remained unchanged 

since we published the February 1992 

final rule with comment period (57 FR 

7002). In the 2018 RFI (83 FR 1005 

through 1006, 1008), we sought public 

comment and information related to 

CLIA personnel requirements in the 

following areas: nursing degrees; 

physical science degrees; personnel 

competency assessment (CA); personnel 

training and experience; and nontraditional degrees. As we explained in 

the 2018 RFI, these are areas that the 

CDC, CMS, interested parties, and State 

agency surveyors identified as relevant 

to our efforts to update the CLIA 

personnel requirements to better reflect 

current knowledge, changes in the 

academic context, and advancements in 

laboratory testing. 

We received approximately 8,700 

comments in response to the 2018 RFI. 

In response to our questions about 

nursing degrees, the majority of 

commenters did not concur that nursing 

degrees were equivalent to a biological 

or chemical sciences degree. However, 

some interested parties suggested 

nursing degrees could be used as a 

separate qualifying degree for 

nonwaived testing personnel (TP). In 

response to our questions about 

physical science degrees as well as nontraditional degrees, interested parties 

commented that a physical science 

degree was hard to define. In 

considering how to evaluate physical 

science and other non-traditional 

degrees, some commenters 

recommended that we evaluate 

coursework taken using a semester-hour 

educational algorithm to qualify 

individuals for CLIA personnel 

positions. If an individual has the 

appropriate coursework without the 

traditional chemical or biological 

degree, the individual’s educational 

coursework should be considered when 

determining whether that individual 

meets the educational requirements 

under CLIA. In response to the 

questions about competency assessment 

(CA), many commenters stated that 

individuals with an applicable associate 

degree should be permitted to perform 

CA on moderate complexity TP. Some 

commenters stated that required 

training should depend on the 

complexity of the testing to be 

performed and that all nonwaived 

testing should require training related to 

the individual’s laboratory 

responsibilities. Several commenters 

also stated that any required training 

and experience should be in a CLIAcertified laboratory. Many commenters 

agreed that all training and experience 

should be documented; many noted that 

documentation from a former employer 

should be acceptable, assuming it 

provided specific details about the 

individual’s job, training, and CA. 

In addition to the 2018 RFI, we 

requested input from CLIAC for 

recommended changes to the CLIA 

personnel requirements found in 

subpart M—Personnel for Nonwaived 

Testing, §§ 493.1351 through 493.1495. 

In response, CLIAC established a 

workgroup that included laboratory 

experts, representatives from 

accreditation organizations (AOs), and 

government. The CLIAC Personnel 

Regulations Workgroup provided 

information and data to CLIAC for their 

deliberation in recommending to HHS 

to update the personnel regulations.12

CLIAC made 12 recommendations at the 

April 2019 meeting to improve CLIA 

personnel regulations, including: (1) 

making biological science degrees 

acceptable for laboratory personnel and 

considering candidates with other 

degree backgrounds based on 

coursework; (2) removing the degree in 

physical science from the CLIA 

regulations due to its broadness; and (3) 

requiring personnel to have training and 

experience in their areas of 

responsibility. 

After the April 2019 CLIAC meeting, 

CMS and CDC met to review and 

consider the recommendations along 

with the information provided in 

response to the 2018 RFI. The following 

CLIAC recommendations support 

proposals included in the July 2022 

proposed rule: 

• Coursework should be considered

in meeting CLIA personnel 

requirements; 

• Degree in physical science should

be removed from CLIA regulations; 

• All personnel should have

appropriate training and experience;

• Remove the statement ‘‘possess

qualifications that are equivalent to 

those required for such certification’’, as 

applicable; 

• Laboratory experience should be

clinical in nature; 

• 20 credit hours of relevant

continuing education should be 

required for all LDs except those 

certified by the American Board of 

Pathology, American Board of 

Osteopathic Pathology, and American 

Board of Dermatology; 

• LDs should make at least two

reasonably spaced onsite visits to the 

laboratories they direct annually. These 

visits should be documented; 

• Modify CLIA requirements for

technical consultants (TC) to include an 

associate degree and training and 

experience; and 

• Modify the definition of mid-level

practitioner to include registered nurse 

anesthetists and clinical nurse 

specialists. 

Following this, CMS and CDC 

collaborated to develop a list of 

personnel regulation updates that we 

proposed in the July 2022 proposed 

rule.13

3. Alternative Sanctions for CoW

Laboratories

As discussed in section III.C. of the 

proposed rule and this final rule, we 

proposed, and are finalizing, an 

amendment to § 493.1804(c)(1) to allow 

CMS to impose alternative sanctions on 

CoW laboratories, as appropriate. CoW 

laboratories are laboratories that only 

perform waived tests, that is, simple 

laboratory examinations and procedures 

that have an insignificant risk of an 

erroneous result. For example, a urine 

dipstick pregnancy test is a waived test. 

The current regulations state that we do 

not impose alternative sanctions on 

CoW laboratories because those 

laboratories are not inspected for 

compliance with condition-level 

requirements (§ 493.1804(c)(1)). 

However, while not subject to the 

biennial routine surveys, CoW 

laboratories are surveyed as a result of 

a complaint, and based on the 

complaint survey, may be found to be 

out of compliance with a conditionlevel requirement. In the absence of 

alternative sanctions, our only recourse 

in cases of compliance issues found at 

CoW laboratories is to apply principal 

sanctions (that is, revocation, 

suspension, or limitation of the CLIA 

certificate). We believe the ability to 

levy alternative sanctions (that is, civil 

money penalties, a directed plan of 

correction, a directed portion of a plan 

of correction, and onsite State 

monitoring) on CoW laboratories helps 

CMS ensure appropriate sanctions are 

applied to CoW laboratories, as in the 

case of other certificate types (certificate 

of PPM, CoR, CoC, CoA). 

In addition, we believe that this 

finalized change will reduce burden on 

CoW laboratories. The ability to impose 

alternative sanctions will be particularly 

useful in instances in which we find PT 

referral violations. PT is the testing of 

unknown samples sent to a laboratory 

by an HHS-approved PT program to 


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check the laboratory’s ability to 

determine the correct testing results. 

This final rule amends the CoW 

regulations at § 493.1804(c)(1) to allow 

for the application of alternative 

sanctions where warranted, in addition 

to or in lieu of principal sanctions. 

We note that while the regulatory text 

at § 493.1804(c)(1) currently specifies 

that CMS will not impose alternative 

sanctions on laboratories that have 

CoWs because those laboratories are not 

inspected for compliance with 

condition-level requirements, this 

distinction is not required by the 

applicable statute at 42 U.S.C. 263a(h). 

Therefore, as discussed in section III.C. 

of this final rule, we proposed to 

remove, and are finalizing the removal 

of, the current parenthetical at 

§ 493.1804(c), which states ‘‘(Except for 

a condition level deficiency under 

§§ 493.41 or 493.1100(a), CMS does not 

impose alternative sanctions on 

laboratories that have certificates of 

waiver because those laboratories are 

not routinely inspected for compliance 

with condition-level requirements.)’’. 

We note that the language ‘‘Except for 

a condition level deficiency under 

§§ 493.41 or 493.1100(a)’’, which was 

inadvertently omitted from the 

discussion of this parenthetical in the 

July 2022 proposed rule, was added in 

the Medicare and Medicaid Programs, 

Clinical Laboratory Improvement 

Amendments (CLIA), and Patient 

Protection and Affordable Care Act; 

Additional Policy and Regulatory 

Revisions in Response to the COVID–19 

Public Health Emergency interim final 

rule with comment period, published in 

the September 2, 2020, Federal Register 

(85 FR 54820). This language was only 

effective during the PHE for COVID–19 

which ended on May 11, 2023. 

Consistent with the finalized 

amendment to remove the current 

parenthetical at § 493.1804(c), this 

language will also be deleted as of the 

effective date of this final rule. 

In responses received from the 2018 

RFI, commenters noted that alternative 

sanctions instead of principal sanctions 

should be an option to create parity for 

all certificate types, especially in cases 

of PT referral. Further, commenters also 

stated that CoW laboratories should be 

held to the same standards and level of 

compliance as those that perform 

moderate complexity and/or high 

complexity testing. 

II. Provisions for CLIA Fees 

This final rule will amend subpart F— 

General Administration in the CLIA 

regulations. This section provides an 

overview of the proposed revisions to 

the CLIA fee requirements established 

by the February 1992 final rule. We also 

summarize and respond to the public 

comments on the July 2022 proposed 

rule and state our final policies. 

A. Definitions of ‘‘Replacement 

Certificate’’ and ‘‘Revised Certificate’’ 

(§ 493.2) 

At § 493.2, we proposed to add 

definitions for ‘‘Replacement 

certificates’’ and ‘‘Revised certificates.’’ 

After several years of experience and 

data analysis, it has been determined 

that the number of reissued certificates 

continues to be remarkable. Reissued 

certificates fall into two different 

categories: revised and replacement 

certificates. For further discussion 

please refer to section II.C. of this final 

rule. We proposed that these definitions 

be added to § 493.2 with the other 

definitions listed to allow clarity in the 

regulations where fees for replacement 

and revised certificates are being 

proposed. 

We did not receive any public 

comments on the proposed definitions 

at § 493.2 of ‘‘replacement certificate’’ or 

‘‘revised certificate’’ and are finalizing 

those definitions as proposed. 

B. Changes to Certificate Fees 

(§ 493.638) 

At § 493.638(a), we proposed to 

amend the regulatory language to clarify 

when a laboratory is required to pay a 

certificate fee and when the certificate is 

issued. We removed the listing of the 

individual certificates in the first 

paragraph of this section as all 

certificates go through the same process. 

The current regulation text specifies 

when a certificate fee is required, but we 

wish to clarify with more specific 

wording. The certificate fee is currently 

incurred when the original certificate is 

issued; when the certificate is 

subsequently renewed; if there is a 

change in certificate type requiring a 

new certificate to be issued; or if a 

lapsed certificate is reactivated with a 

gap in service and therefore reissued. 

The intent of the regulation is not 

changing. We believe adding this 

clarification would improve 

transparency concerning the 

requirement to pay certificate fees. 

Specifically, at § 493.638(a)(1) for 

registration certificates, we proposed to 

remove the reference to the CoC because 

we believe the flat fee charged for a CoR 

and the temporary nature of the 

certificate require a separate section. We 

proposed to redesignate the fees 

associated with a CoC to a new 

provision at § 493.638(a)(5) to keep fee 

information relevant to the different 

certificate types separate, rather than 

referencing the certificate types 

together. 

At § 493.638(a)(2) for CoW, we 

proposed to add the costs incurred by 

FDA to determine whether a test system 

meets the criteria for waived status, as 

specified at § 493.15(d). A CMS 

representative reviews an application 

for a CoW to determine whether the 

applicant has requested a CLIA 

certificate that covers the testing they 

have listed on the application that they 

will be performing. The cost of such a 

review is already part of the CoW fee. 

However, FDA must expend resources 

reviewing tests, procedures, and 

examinations to determine whether a 

test meets the criteria to be designated 

as waived. This expense is not currently 

captured in the fee for a CoW, and we 

proposed that it should be. HHS had 

delegated the responsibility to FDA for 

the review of test systems and 

assignment of complexity, including 

what is required by § 493.15(d). CMS 

compensates FDA out of the CLIA funds 

for this determination under the CMS– 

FDA MOU (IA19–23). CoW laboratories 

are restricted to using waived tests. We 

believe that the regulatory restrictions of 

test systems for the CoW laboratories 

and the CMS requirement to determine 

what tests can be performed in a CoW 

laboratory under § 493.15(d) require us 

to place this fee on the CoW laboratories 

alone. We believe the predicted increase 

in CoW laboratories will offset expected 

increases in the obligation to FDA for 

the continued process of review and 

categorization of tests as waived. 

We proposed to make editorial 

changes to clarify the current provision 

§ 493.638(b) that describes certificate fee 

amounts. We proposed to separate this 

section into four shorter paragraphs 

designated as § 493.638(b)(1) through 

(4). Proposed § 493.638(b)(1) stated that 

CMS will publish a notice in the 

Federal Register when assessed fees are 

adjusted in accordance with § 493.680. 

This section also includes a brief 

discussion of the basis for certificate 

fees as set forth in § 493.638(c). 

Proposed § 493.638(b)(2) stated that 

certificate fees would be collected at 

least biennially. Certificate fees may be 

assessed more frequently than every 2 

years if the laboratory changes its 

certificate type. Proposed 

§ 493.638(b)(3) stated how fees would be 

determined and proposed 

§ 493.638(b)(4) stated that CMS would 

notify the laboratories when the fees are 

due and the fee amount. This currently 

takes place in the form of a fee coupon 

sent through U.S. Mail by the Billing 

and Certificate Issuance contractor. 

We also proposed to move the 

regulatory text currently found at 


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§ 493.643(c)(1) through (3) to a new 

provision at § 493.638(c) to align the 

provisions more closely for laboratory 

schedules and specialties with the 

related provisions concerning certificate 

fees. Our intent is to refer back to this 

provision when the compliance fees are 

discussed. In addition to redesignating 

this regulatory text, we proposed 

making minor changes to clarify the 

regulatory text related to specialties of 

service before those specialties are 

explained at § 493.643(c)(3). 

At the proposed new § 493.638(c)(3), 

we proposed to redesignate the 

regulatory text currently at 

§ 493.643(c)(1) with changes. We believe 

that the separation of Schedule A into 

two parts at § 493.643(c)(1)(i)(A) and (B) 

was confusing, and we proposed listing 

them as separate schedules. The 

proposed text in the new provision 

§ 493.638(c)(3) included 

§ 493.638(c)(3)(i) through (xi). At 

§ 493.638(c)(3)(i), we proposed 

describing the low volume schedule as 

Schedule V to differentiate it from 

Schedule A, proposed at 

§ 493.638(c)(3)(ii). Current data 

processing system requirements have 

been built to refer to the low volume A 

schedule laboratories as Schedule V and 

will continue with the new data system. 

We received public comments on 

these proposals. The following is a 

summary of the public comments we 

received and our responses. 

Comment: Several commenters 

supported the proposed increase in fees, 

including the fees for replacement 

certificates. However, several other 

commenters expressed concerns about 

the fee increase and new fees, 

specifically, the potential impact on 

rural areas or smaller laboratories, 

including private physician office 

laboratories. Commenters stated 

laboratories in this defined population 

may need to limit, reduce or 

discontinue services, which would 

negatively impact the populations 

served. Commenters stated many 

laboratories already experience 

hardship with growing labor costs, 

combined with shortages and increased 

costs of supplies and that raising CLIA 

fees presents another hardship. Several 

commenters expressed concerns about 

raising the CLIA laboratory fees during 

a time when CMS has made cuts to 

laboratory test reimbursement under the 

Protecting Access to Medicare Act 

(PAMA). The commenters stated that 

broad increases in regulatory costs may 

adversely impact the ability to provide 

clinical laboratory services, particularly 

in resource-limited settings. 

Response: As a user-fee funded 

program, CLIA must collect fees to cover 

the cost of implementing the program. 

However, the existing fee collections are 

not sufficient to cover total costs of 

laboratory oversight. The CLIA fees are 

structured on annual test volume and 

number of specialties so that smaller 

(lower annual test volume) laboratories’ 

fees are less than larger (higher annual 

test volume) laboratories. The fee 

increase allows us to fund and sustain 

the CLIA program to ensure oversight of 

laboratory testing. We note that 

reimbursement rates are outside the 

scope of the rule, are set by statute, and 

are not related to raising the CLIA fees. 

Comment: Several commenters 

requested CMS provide transparency in 

how the 20 percent increase in 2019 

stabilized the CLIA program and 

publish additional detail related to the 

CLIA total program costs. 

Response: We thank the commenters 

for these comments. The funds collected 

in the CLIA program must maintain 

funding levels to sustain the program. 

The 2019 20 percent across the board 

increase was used to shore up the 

program facing crucial deficiencies at 

that time. The increase implemented in 

this final rule is meant to stabilize the 

program so that adjustments based on 

inflation will apply automatically. 

While we proposed a 20 percent across 

the board increase, based upon our 

analysis in section I. of this final rule 

and Table 3, we are instead finalizing an 

18 percent across the board increase 

based on consideration of updated 

inflation assumptions, laboratory 

counts, workload estimates and 

available funds. CMS reviewed updated 

estimates of program spending, user fee 

collections, carryover, and inflation. As 

displayed in Table 3, we found that 

increases in actual carryover, actual 

collections, new and increased fee 

collections and estimated changes in 

CPI–U, when applied to actual program 

obligations, allowed CMS to assess a 

lower across-the-board inflation factor 

to the existing user fees and still meet 

planned carryover targets. 

Comment: A commenter stated that 

the activities associated with processing 

CLIA certificates of waiver at the State 

Agency should be allocated more 

effectively. 

Response: We appreciate the 

commenter’s input, but this is outside 

the scope of the rule. The fees from all 

collections are used to support the 

whole of the CLIA program including 

activities for waived laboratories and 

the FDA’s role in categorizing tests and 

test systems as waived. 

Comment: Several commenters 

expressed concerns that the fee increase 

will negatively impact the small office 

laboratories and private physician 

laboratories as these types of 

laboratories will not be profitable 

enough to offer services or will severely 

limit services. Commenters further 

expressed concerns that most of these 

laboratories are still being negatively 

impacted by the public health 

emergency and requested that CMS 

consider suspending the fee increase for 

these laboratory types for at least 2 

years. 

Response: The CLIA regulations were 

framed to establish quality standards for 

all laboratories regardless of size or 

facility type. As such, collection of fees 

from all types of laboratories is 

necessary in order for the program to be 

self-funded as mandated by statute. As 

previously noted, the CLIA fee schedule 

is structured so that the lowest volume 

laboratories pay the lowest CLIA fees. 

We appreciate the commenters sharing 

these concerns, but believe it is 

necessary to finalize the proposed fee 

increase at this time in order to sustain 

the CLIA program. 

After consideration of the comments 

received, we are finalizing the proposed 

changes to § 493.638 without 

modification. As discussed previously, 

after recalculating the needs of the 

program using updated data, we are 

finalizing an across the board increase 

of 18 percent that will be applied to all 

fees, except for replacement and revised 

certificates. 

C. Changes to Fees for Revised and 

Replacement Certificates (§ 493.639) 

At § 493.639, we proposed to revise 

the current section heading (‘‘Fee for 

revised certificate’’) to read as ‘‘Fee for 

revised and replacement certificates’’ to 

match the contents of the section as 

amended to include both revised 

certificates and replacement certificates. 

We proposed to define and explain 

revised and replacement certificates in 

section II.A. of the proposed rule. In the 

proposed provision at § 493.639, we 

explained the fees associated with each 

type. 

At § 493.639(a), we proposed 

removing the reference to registration 

certificates as the section applies to all 

CLIA certificate types under the 

statutes. We also proposed to amend the 

circumstances in which a laboratory 

may request a revised certificate to 

include changes to laboratory name and 

location, LD, or services offered 

(specialties and subspecialties). We 

proposed the fee be based on the 

national average cost to issue the 

revised certificate. However, due to 

differing amounts of work required per 

certificate type, the fee is not the same 

for all certificate types. Please see Table 

6. 


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We determined the time and 

resources required to enter changes to 

laboratory demographics, review of 

specialties and subspecialties, and 

review of LD qualifications using an 

average of the State survey agencies’ 

calculated unit hourly cost. The State 

unit hourly cost is determined by the 

CLIA budget office and is based on a 

formula of total State costs divided by 

the total paid hours. The total State 

costs are reported to CMS by the State 

survey agencies and include staff 

salaries as determined by each State’s 

civil service pay scale, fringe benefits, 

travel costs, and other costs such as 

office supplies, computers containing 

software required to perform and report 

a CLIA survey, etc. The total staff year 

hours are determined by multiplying the 

number of full-time employees (FTE) by 

1600 hours, representing the productive 

work year. 

The time and resources for State 

agencies to enter demographic changes 

are less than those where the 

qualifications of the LD or services need 

to be reviewed to ensure CLIA 

personnel requirements are met. Review 

of LD qualifications applies to 

laboratories holding a CoC, a certificate 

for PPM, or CoR. 

AOs are responsible for reviewing 

CoA LD qualifications, and the AO is 

also responsible for reviewing the 

addition of specialties and 

subspecialties for the CoA laboratory. 

As such, State agency staff are not 

responsible for reviewing LD 

qualifications or changes in specialties/ 

subspecialties for laboratories with a 

CoA; however, they are responsible for 

processing the other demographic 

change requests for CoA laboratories. 

Therefore, a revised certificate for a CoA 

laboratory does not include the cost to 

review the qualifications of LDs, nor 

does it include the adding or deleting of 

specialties or subspecialties. 

For a CoC, a change in services 

(adding or deleting a specialty or 

subspecialty) does not include review to 

determine compliance with the 

regulations for services added; however, 

the entry or deletion of specialty or 

subspecialty changes requires State 

agency personnel time and resources. 

CLIA personnel requirements are not 

required for laboratories with a CoW, 

nor are there specialty or subspecialty 

requirements. Therefore, the time and 

resources required to enter requested 

demographic changes for CoW 

laboratories are less than for other 

certificate types. Please see the section 

below for the calculations used to 

determine these fee amounts. 

We proposed the following fees for 

issuing revised certificates: 

The revised certificate fee would be 

paid prior to the issuance of the revised 

certificate. 

At § 493.639(a)(1), we proposed a new 

provision explaining that the addition of 

services (that is, specialties/ 

subspecialties) for laboratories with a 

CoC may result in an additional fee for 

purposes of determination of 

compliance if added services require an 

inspection. That addition of the 

specialties inspection fee is described in 

a new provision at § 493.643(d)(2). 

We proposed to delete the current 

provisions at § 493.639(b)(1) and (2), 

which provide information on fees for 

issuing a revised certificate and 

scenarios that describe changes that may 

require a change in certificate. We 

proposed to replace them with a new 

provision at § 493.639(b) that outlines 

fees for issuing a replacement 

certificate. We believe the current 

provisions are confusing as written as is 

the location of the provisions in the 

regulations. 

At the new provision § 493.639(b), we 

proposed a fee for issuance of 

replacement certificates as discussed in 

section II.A. of the proposed rule. The 

proposed requirement must account for 

the time and resources required to issue 

a replacement certificate when 

requested. Historically, replacement 

certificates have been issued without 

additional fees when a laboratory loses 

or destroys its current certificate. As 

discussed in the proposed rule, we have 

determined that the actual cost of 

issuing a replacement certificate is 

$75.00. A replacement certificate is one 

where no changes are being requested. 

The fee would be paid prior to the 

issuance of the replacement certificate. 

The initial calculations used to 

determine the proposed fee amounts for 

replacement certificates, and revised 

certificates were based on the time, and 

the average State unit costs for 2019 

when these fees were set. When these 

calculations were made, the national 

average unit hourly cost in 2019 was 

$72.06. It was determined that it took 

State agency personnel approximately 

45 minutes to receive, review, and enter 

a request for a replacement certificate 

and another 15 minutes to print and 

mail the certificate. Using these 

estimates, the cost of the replacement 

certificate is calculated to cost the CLIA 

program $75.00 currently. 

Furthermore, CMS determined that 

additional State agency resources are 

expended when issuing revised 

certificates as follows: 

• An additional 15–20 minutes to 

review and enter requested 

demographic changes or $20.00 for all 

certificate types. 

• An additional 45 minutes to review 

and enter requested laboratory director 

changes or specialty changes for $55.00 

for revised CoRs, CoCs, and PPMs. 

These additional costs are therefore 

reflected in the proposed fees for issuing 

revised certificates. (See Table 6) 

We received public comments on 

these proposals. The following is a 

summary of the public comments we 

received and our response. 

Comment: Several commenters 

suggested CMS establish a process that 

would allow a laboratory to print its 

own certificates, rather than having to 

request and pay a replacement 

certificate fee as proposed. The 

commenters asserted that the 

established process of mailing and 

relying on mail delivery service is 

outdated and antiquated and that often 

the laboratory may not receive a copy of 

the certificate, due to mail delivery 

interruptions. 

Response: We thank the commenters 

for this suggestion. As of March 2023, 


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TABLE 6: CMS Proposed Fee for Issuance of Revised Certificate 

Certificate Type Fee 

cow $95.00 

CoA $95.00 

CoR $150.00 

Coe $150.00 

PPM $150.00 
89992 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

14https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/ 

som107ap_c_lab.pdf. 

CMS began issuing a link to electronic 

certificates so laboratories could print 

their own certificate. 

After consideration of the comments 

received, we are finalizing the proposed 

changes to § 493.639 without 

modification. 

D. Changes to Fees Applicable to 

Laboratories Issued a CoC (§ 493.643) 

At § 493.643, we proposed renaming 

the section heading ‘‘Fee for 

determination of program compliance’’ 

to ‘‘Additional fees applicable to 

laboratories issued a certificate of 

compliance’’ for clarification. 

We proposed adding language at 

§ 493.643(b) to describe the costs 

included in the fee for routine 

inspections to increase transparency. 

We proposed deleting the second 

sentence of § 493.643(b) in 

consideration of a two-part biennial fee 

increase as discussed under section II.H. 

(§ 493.680) of the proposed rule and this 

final rule. For clarity, we proposed to 

redesignate the third sentence of the 

current provision at § 493.643(b) as 

§ 493.643(c). 

At the new provision § 493.643(c)(1), 

we proposed that the inspection fee will 

be based on the schedules of the 

laboratories as defined in the new 

provision under § 493.638(c)(3). The fee 

amounts assigned to the schedules in 

the February 1992 final rule were based 

on an estimated number of hours to 

perform a survey of a laboratory with 

the scope and volume associated with 

each schedule multiplied by an 

estimated 1992 hourly rate for a 

surveyor of $35.00. The established 

hourly rate of $35.00 was intended to be 

used as a baseline and then revised after 

actual data were collected and 

experience gained (57 FR 7193). In 1992 

it was anticipated that the universe of 

regulated laboratories would be much 

greater than those regulated prior to the 

implementation of CLIA ‘88. 

The hourly rate for performing 

laboratory surveys is recalculated by 

CMS for each State annually to 

determine the CLIA obligation to 

support the State survey agencies but 

has not been used to increase CLIA fees 

on an ongoing basis. The national 

average hourly rate in 2023 is $108.78, 

to reflect updated data. A description of 

the national average hourly rate 

calculation is provided in section II.C. 

of the proposed rule. 

Extensive data collected over time 

now enables us to better estimate the 

number of hours it takes for a surveyor 

to perform an inspection of a laboratory 

within each schedule. Such estimates 

are primarily driven by the scope and 

volume of tests run by the laboratory 

and the laboratory’s compliance with 

the CLIA regulations. A laboratory with 

a high-test volume and multiple 

specialties may have processes and 

practices that allow it to meet and 

exceed CLIA regulations as they operate 

with a high degree of quality and 

efficiency while ensuring reported 

results are accurate and timely to 

provide optimum patient care. The 

surveyor will likely spend less time on 

inspecting that laboratory. In contrast, if 

a laboratory with a small test volume 

and few specialties does not have 

processes and practices that allow it to 

operate with the same high degree of 

quality and efficiency, such a laboratory 

is likely not to meet the CLIA 

requirements. Such laboratories may be 

reporting test results that may not be 

accurate and reliable. While the test 

volume may be low, the surveyor will 

likely spend additional time surveying 

such laboratories due to the less-thanoptimal operations and processes. 

Conversely, the number of hours 

needed to survey a large laboratory with 

poor compliance history could be quite 

large. The surveyor would spend more 

time in this laboratory, and given the 

size and poor compliance history, the 

surveyor would review the prior survey 

deficiencies to ensure the laboratory’s 

monitors put into place have corrected 

the deficiency. In contrast, a surveyor 

may not need to spend as many hours 

to survey a laboratory with lower test 

volume and specialties and a favorable 

compliance history. Taking each 

scenario into account, we believe the 

average number of hours a surveyor 

spends in each laboratory reflects the 

universe of laboratories within each 

schedule. Thus, as we explained in the 

proposed rule, we will not be changing 

the differences between the amounts of 

the fees within the compliance fee 

schedules relative to each other. They 

will remain in their relative amounts 

and be increased across the board by the 

same percentage in the proposed twopart fee increase (section II.H. 

(§ 493.680) of the proposed rule and this 

final rule). 

Table 7 illustrates the different 

scenarios mentioned previously in the 

proposed rule and this final rule and 

how the number of hours spent on the 

survey vary based on both the size (the 

schedule) of the laboratory and poor 

compliance with the CLIA regulations. 

Poor compliance is being defined for 

this illustration as a laboratory with at 

least one condition-level deficiency 

cited during a survey. For information 

about condition-level deficiencies, 

please see the CLIA website for the 

Interpretive Guidelines for Laboratories, 

Appendix C: Interpretive Guidelines.14


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As illustrated in Table 7, survey hours 

in small laboratories without condition 

level deficiencies averaged 12 hours. In 

contrast, survey hours in small 

(schedules V–A) laboratories with 

condition level deficiencies averaged 18 

hours. In the largest (schedule J) 

laboratories, survey hours differed from 

an average of 32 hours spent in 

laboratories without condition level 

deficiencies compared to 75 hours in 

those laboratories that had condition 

level deficiencies cited. 

The February 1992 final rule did not 

consider other costs involved in the 

inspection process, such as continuous 

training of the State surveyors and 

monitoring of the State agency program 

processes by the CMS Locations 

(Regional Offices). The CLIA program 

has created and continuously updates 

periodic training for surveyors through 

online training modules, onsite 

meetings, and conference calls. 

The surveyors are individually 

monitored with a Federal Monitoring 

Survey (FMS) process where CMS 

location (Regional Office) Federal 

surveyors observe the individual State 

surveyor on a survey or perform a 

survey of the same laboratory after the 

State surveyor has completed their 

survey to confirm that the State 

surveyor is competent and following the 

prescribed survey process. The CMS 

locations (Regional Offices) also perform 

an annual State Agency Performance 

Review (SAPR) for each State survey 

agency, including a review of the State 

survey agency’s training processes and 

monitoring processes for their State 

surveyors. This includes a review of the 

deficiency reports State surveyors have 

sent to laboratories to determine that the 

surveyor is following the program’s 

principles of documentation and the 

proper survey process. 

There are also costs to the program to 

maintain a computerized system for 

entering inspection findings and 

compliance monitoring, including 

proficiency testing. The computer 

system also allows the CMS locations to 

run reports to monitor the inspections 

entered by the State surveyors. 

The compliance fees have historically 

been based on the costs to the CLIA 

program for the State agencies. These 

aforementioned activities are obligations 

outside of the State survey agency 

annual budgets. We therefore proposed 

that inspection fees for laboratories in 

each schedule and State will no longer 

be determined solely by the estimated 

hours spent on a survey of a laboratory 

within each schedule nor by the 

surveyor hourly rate of $35.00 

established in 1992. 

We believe that the compliance fees 

currently set within the schedules 

should continue to be used but that 

additional fees, as previously described, 

should be added to the regulatory 

scheme. All fees would be increased 

biennially following the biennial twopart fee increase as proposed in the 

proposed rule in § 493.680. 

We believe we are authorized to 

calculate these fees per laboratory 

schedule (or group) even though the fees 

will no longer be determined solely by 

the estimated hours spent on a survey 

of a laboratory within each schedule nor 

by the 1992 surveyor hourly rate of 

$35.00 based on section 353(m)(3)(C) of 

the PHSA, which states that, fees shall 

vary by group or classification of 

laboratory, based on such 

considerations as the Secretary 

determines are relevant, which may 

include the dollar volume and scope of 

the testing being performed by the 

laboratories. As discussed in the 

proposed rule, we believe our proposals 

are within the bounds of our authority 

under the PHSA. 

At § 493.643(c)(2), we proposed to 

redesignate language from the current 

§ 493.643(b) which states the fees are 

assessed and payable biennially. We 

stated that we believe this will support 

the two-part fee increase proposed in 

the proposed rule and described in 

§ 493.680. 

At the new provision § 493.643(c)(3), 

we proposed that the fee amount would 

be the amount applicable to a given 

laboratory increase listed in the most 

recent published CLIA fee increase 

notice in the Federal Register. 

We proposed to redesignate current 

§ 493.643(d)(1) and (2) where additional 

fees for CoC laboratories are discussed 

as § 493.643(d)(2) and (3) and to 

redesignate the fourth and fifth 

sentences of current provision 

§ 493.643(b) where an additional fee for 

a follow-up survey on a CoC laboratory 

is discussed as a new provision at 

§ 493.643(d)(1). We believe the 

discussion of additional fees for CoC 

laboratories should be grouped together. 

We proposed to move the current 

regulatory text at § 493.643(d)(2) to 

§ 493.643(d)(3) with no changes. Current 

regulation allows additional fees to be 

assessed for substantiated complaints; 

however, this has not been 

implemented. The proposed rule would 


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TABLE 7: Survey Hours with Condition-Level Deficiencies Cited vs. Not Cited by 

Schedule Code 

Condition Level Deficiencies Not Cited Condition Level Deficiencies Cited 

Schedule code Range of hours Range of hours required 

of Number of required to perform Number of to perform the 

laboratories laboratories** the individual surveys laboratories** individual surveys and 

that were and the average (avg) the average (avg) 

surveyed* number hours** number of hours** 

V-A 3,446 4 - 69 (avg: 12) 661 5 - 143 (avg: 18) 

B-C 1,328 4 - 69 (avg: 13) 320 7 - 123 (avg: 19) 

D-E 972 4 - 79 (avg: 15) 261 6 - 201 (avg: 23) 

F-G 727 5 - 165 (avg: 18) 192 6 - 378 (avg: 30) 

H-1 935 5 - 284 (avg: 21) 279 7 - 497 (avg: 41) 

J 1IO 8 - 213 (avg: 32) 23 8 - 378 (avg: 75) 

*For a description of the schedules see the section of this document with the proposed amendments to 42 CFR chapter IV, 

specifically provision§ 493.638(c). The schedules have been grouped as two schedules together to keep the size of the table to a 

minimum. We did not propose to change the schedules this way. 

**The data comes from the SAS Viya system for surveys completed between 10-01-2017 and 09-30-2019 with condition-level 

deficiencies not cited versus condition level deficiencies cited and separated by schedule codes. 
89994 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

implement fees for substantiated 

complaints, meaning those complaints 

where the allegations against the 

laboratory were found to be true by 

CMS. We believe implementing the fee 

for substantiated complaints would 

cover the costs required to perform such 

a survey, including documenting the 

deficiencies found to be violated, 

preparing a report for the laboratory, 

and review of the laboratory’s plan of 

correction and monitoring their 

correction. The fee was proposed to be 

limited to the cost of the actual time and 

resources required for these activities. 

At new provision § 493.643(d)(4), we 

proposed to establish an additional fee 

for CoC laboratories that are found to 

have unsuccessful PT through a PT desk 

review. Current policy requires the 

review of PT performance every 30–45 

days for each laboratory with a CoC that 

performs testing and is enrolled in PT 

for an analyte or test included in 

subpart I. Cases of unsuccessful PT 

performance require a PT desk review to 

confirm. Upon confirmation, the 

laboratory is notified of its regulatory 

requirement to investigate and correct 

the unsuccessful PT performance. 

Currently, such PT desk reviews do not 

generate an additional fee; however, 

conducting the desk review requires 

surveyor time and resources. We believe 

this new fee would cover the costs of 

the desk review, including documenting 

the deficiencies found to be violated, 

preparing a report for the laboratory, 

and reviewing the laboratory’s plan of 

correction and monitoring their 

correction. The proposed fee is to be 

limited to the cost of the actual time and 

resources required for these activities. 

We stated in the proposed rule that only 

laboratories with unsuccessful PT 

performance would be impacted if this 

rule is finalized. 

The fees described in § 493.643(d) 

must be paid, or HHS will revoke the 

laboratory’s CoC. 

We did not receive public comments 

on the proposed changes to § 493.643 

and are finalizing as proposed. 

E. Changes to Additional Fees 

Applicable to Laboratories Issued a 

CoA, CoW, or Certificate for PPM 

Procedures (§ 493.645) 

At § 493.645, we proposed to change 

the current section heading 

(‘‘Additional fee(s) applicable to 

approved State laboratory programs and 

laboratories issued a certificate of 

accreditation, certificate of waiver, or 

certificate for PPM procedures’’) to 

clarify the contents of the section as 

amended. The proposed title was 

‘‘Additional fees applicable to 

laboratories issued a certificate of 

accreditation, certificate of waiver, or 

certificate for PPM procedures.’’ 

We proposed to move in its entirety 

the regulatory text regarding the fee we 

charge State laboratory programs for 

costs related to their CLIA-exempt 

laboratories in § 493.645(a)(1) through 

(3) to § 493.649(a)(1) through (3). We 

believe the fees for approved State 

laboratory programs should be listed 

separately from the other CLIA-certified 

laboratories in the regulations. A State 

laboratory program is a laboratory 

program that HHS approves as exempt 

due to the State requirements being 

equal to or more stringent than the CLIA 

requirements. Under such programs, the 

State provides regulatory oversight of its 

laboratories in lieu of such laboratories 

being regulated by HHS. HHS approves 

and monitors such State laboratory 

programs to ensure that the standards of 

the State laboratory programs are and 

remain at least as stringent as the CLIA 

regulations. HHS does not impose fees 

on laboratories covered by these 

programs but charges a fee to the 

program as described in the new 

provision at § 493.649. 

We proposed making editorial 

corrections to the references of 

§§ 493.645(a) and 493.646 noted in 

§§ 493.557(b)(4) and 493.575(i) and 

replacing those references with 

§§ 493.649(a) and 493.655(b). The 

requirements previously included at 

§§ 493.645(a) and 493.646(b) governing 

applicable fees were proposed to be 

redesignated as § 493.649(a) and new 

§ 493.655(b). 

We further proposed redesignating 

current § 493.645(b)(1) and (2) regarding 

the payment of inspection fees as new 

§ 493.645(a)(1) and (2). We proposed 

new § 493.645(a)(1) to clarify the 

amount accredited laboratories pay for 

their inspection (validation survey) fees 

by removing the last sentence of the 

current regulatory text, which reads that 

these costs are the same as those that are 

incurred when inspecting nonaccredited 

laboratories. We believe this does not 

fully explain how the fee is determined. 

This fee is based on fees that CoC 

laboratories pay for compliance 

inspections; however, an accredited 

laboratory is only assessed 5 percent of 

the fee a CoC laboratory pays because 

only 5 percent of CoA laboratories are 

inspected (undergo a validation survey) 

annually. For example, a CoC laboratory 

classified as ‘‘schedule D’’ currently 

pays an average biennial compliance fee 

of $2,336.00. The accredited laboratory 

classified as ‘‘schedule D’’ would 

currently pay an average biennial 

inspection (validation survey) fee of 

$117.00. 

At new § 493.645(a)(2), we proposed 

redesignating the provision from current 

§ 493.645(b)(2), with no changes. This 

provision established an additional fee 

if a laboratory issued a CoA were to be 

inspected and follow-up visits were 

necessary because of identified 

deficiencies. Historically this fee had 

not been implemented due to technical 

difficulties described previously in the 

proposed rule. We proposed that it be 

implemented. As stated in the current 

regulatory text, the additional fee to 

cover the cost of these follow-up visits 

would be based on the actual resources 

and time necessary to perform the 

follow-up visits. Also, as stated in the 

regulatory text, HHS would revoke the 

laboratory’s CoA for failure to pay the 

fee. 

At new § 493.645(b), we proposed 

redesignating the provision from current 

§ 493.645(c). This provision established 

a fee for substantiated complaint 

surveys, those in which the allegations 

against the laboratory were found to be 

true, on CoA, CoW, or certificate for 

PPM procedures laboratories. 

Historically, this fee has not been 

implemented. We believe implementing 

the fee for substantiated complaints 

would cover the costs required to 

perform such a survey, including 

documenting the deficiencies found to 

be violated, preparing a report for the 

laboratory, and review of the 

laboratory’s plan of correction and 

monitoring their correction. The fee is 

limited to the actual time and resources 

required for these activities. 

We did not receive public comments 

on the proposed changes to §§ 493.557, 

493.575, and 493.645 and are finalizing 

as proposed. 

F. Changes to Additional Fees 

Applicable to Approved State 

Laboratory Programs (§ 493.649) 

At § 493.649, we proposed to delete 

the current language in its entirety and 

replace it with language from 

§ 493.645(a)(1) through (3). We stated in 

the proposed rule that the current 

provision at § 493.649 would no longer 

be needed as the methodology for 

determining inspection fees because the 

proposed rule was not based on a 

surveyor hourly rate. At new § 493.649, 

we proposed revising the current 

section heading (‘‘Methodology for 

determining fee amount’’) to give a clear 

meaning of the contents of the section 

as amended. The proposed title was 

‘‘Additional fees applicable to approved 

State laboratory programs.’’ We 

proposed replacing the current language 

with current provisions § 493.645(a)(1) 

through (3) with minor changes 

(removing ‘‘costs of’’ from current 


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15 60 FR 20047, April 24, 1995 (https://

www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/ 

95-9953.pdf#page=13). 

16 68 FR 3640, January 24, 2003 (https://

www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/ 

03-1230.pdf). 

493.469(a)(3)). The provisions at 

§ 493.645(a)(1) through (3) outline the 

fees applicable to approved State 

laboratory programs and have been 

comingled with the provision that 

outlines the fees for accredited PPM and 

CoW laboratories. We believe separating 

this provision from the other laboratory 

certificate types will allow for improved 

readability and understanding. 

We did not receive public comments 

on the proposed changes at § 493.649 

and are finalizing as proposed. 

G. Changes to Payment of Fees 

(§§ 493.646 and 493.655) 

At § 493.646, we proposed 

redesignating the current provision with 

minor changes corresponding to the 

validation survey cost as new § 493.655 

and including a reference to § 493.563 

that contains the validation inspection 

information. We believe this provision 

which outlines the payment of fees, is 

better placed after discussions of the 

different types of fees. 

We proposed redesignating 

§ 493.646(a) and (b) where the payment 

of fees is discussed to new provisions at 

§ 493.655(a) and (b) with a minor 

change referencing approved State 

laboratory programs instead of Stateexempt laboratories. The State program 

pays CMS, not the individual 

laboratories. 

We did not receive public comments 

on the proposed changes at §§ 493.646 

and 493.655 and are finalizing as 

proposed. 

H. Methodology for Determining the 

Biennial Fee Increase (§ 493.680) 

At new provision § 493.680, we 

proposed a biennial two-part fee 

increase, which would be calculated as 

described in section I.B. of the proposed 

rule and published as a notice with a 

comment period at least biennially. 

Should the off-year of the biennial 

increase result in unexpected program 

obligations, CMS may need to calculate 

an additional fee increase based on 

either the CPI–U or difference in 

obligations and total collected fees or a 

combination of both. Any unexpected 

program obligations that are identified 

during the off-year would be 

incorporated into the biennial increase. 

All fees, existing and proposed, 

mentioned in the proposed rule would 

also be subject to the biennial two-part 

fee increase. 

We did not receive public comments 

on proposed § 493.680 and are finalizing 

as proposed. 

III. Provisions for CLIA Requirements 

for Histocompatibility, Personnel, and 

Alternative Sanctions for CoW 

Laboratories 

This final rule amends subpart K— 

Quality System for Nonwaived Testing, 

subpart M—Personnel for Nonwaived 

Testing, and subpart R—Enforcement 

Procedures in the CLIA regulations. 

This section provides an overview of the 

proposed revisions to the CLIA 

requirements for histocompatibility, 

personnel, and application of alternative 

sanctions for CoW laboratories 

originally established by the February 

1992 final rule with comment period (57 

FR 7002), subsequently modified in 

1995 15 and 2003,16 and currently 

specified in subpart A—General 

Provisions, subpart K—Quality System 

for Nonwaived Testing, subpart M— 

Personnel for Nonwaived Testing, and 

subpart R—Enforcement Procedures. We 

also summarize and respond to 

comments on the July 2022 proposed 

rule in this section and summarize the 

final actions for each of the new or 

revised sections of the regulations. 

We received 20,574 public comments 

in response to the July 2022 proposed 

rule. The commenters represented 

individuals, laboratory accreditation 

organizations, laboratory professional 

organizations, government agencies, 

healthcare organizations, and 

businesses, including in vitro 

diagnostics manufacturers. The majority 

of the comments were a standard ‘‘form 

letter’’ opposing the proposal to include 

nursing degrees in the qualifications for 

high complexity testing personnel. In 

addition to the duplicate form letters, 

we received over 750 comments related 

to the inclusion of nursing degrees for 

moderate and high testing personnel 

qualifications. 

A. Changes to Histocompatibility 

Requirements 

In the proposed rule, we proposed to 

amend the histocompatibility 

regulations under CLIA by removing 

obsolete regulations and removing 

requirements that are also imposed 

under the general requirements. We also 

proposed to update the 

histocompatibility regulations to 

incorporate current practices and 

technological changes in Human 

leukocyte antigen (HLA) typing, 

antibody screening and identification, 

crossmatching and transplantation. 

1. General, Human leukocyte antigen 

(HLA) Typing, Disease-Associated 

Studies, and Antibody Screening and 

Identification (§ 493.1278(a) through 

(d)) 

At § 493.1278(a)(1), we proposed to 

amend the requirement by changing ‘‘an 

audible alarms system’’ to ‘‘a 

continuous monitoring and alert 

system’’ because this allows the 

laboratories more flexibility in 

determining the best way to monitor 

refrigerator temperatures. It is very 

important to monitor temperatures 

continuously, so that recipient and 

donor specimens and reagents are stored 

at the appropriate temperature to ensure 

accurate and reliable testing. 

At § 493.1278(a)(2), we proposed to 

modify the requirement by expanding 

the regulatory language to include that 

the laboratory must establish and follow 

written policies and procedures for the 

storage and retention of patient 

specimens based on the specific type of 

specimen because the type and duration 

of specimen storage are equally 

important as ease of retrieval. We are 

retaining the requirement that stored 

specimens must be easily retrievable. 

At § 493.1278(a)(3), we proposed 

deleting the labeling requirement for inhouse prepared typing sera reagent. If a 

laboratory is performing 

histocompatibility testing, this 

requirement under the general reagent 

labeling requirements for all test 

systems must be met under 

§ 493.1252(c) and, therefore, is 

duplicative. 

At § 493.1278(a)(4), we proposed to 

revise this requirement by removing the 

examples (that is, antibodies, antibodycoated particles, or complement) to 

clarify that these technologies, as well 

as current and future technologies, are 

allowed for the isolation of lymphocytes 

or lymphocyte subsets. We also 

proposed clarifying the requirement by 

adding ‘‘identification’’ of lymphocytes, 

or lymphocyte subsets. In this type of 

testing, lymphocytes can be isolated, but 

the subsets (B and T cells) are identified 

rather than isolated. Due to the 

proposed changes to § 493.1278(a)(3), 

we also proposed to redesignate 

§ 493.1278(a)(4) as revised to 

§ 493.1278(a)(3). 

We proposed the current requirement 

at § 493.1278(a)(5) would be 

redesignated as § 493.1278(a)(4). This 

requirement remains unchanged. 

At § 493.1278(b)(1) through (3), we 

proposed deleting these requirements 

pertaining to establishing HLA typing 

procedures. The requirement that the 

laboratory must establish and have 

written procedures that ensure quality 


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test results are already addressed by the 

general requirements for all test systems 

under current § 493.1445(e)(1) and 

(e)(3)(i) and revision at § 493.1278(f), 

respectively, and therefore, are 

duplicative. 

The July 2022 proposed rule 

inadvertently omitted a technical 

change at proposed redesignated 

§ 493.1278(b)(1) to reflect the current 

name of the World Health Organization 

(WHO) committee that determines HLA 

nomenclature, the ‘‘Nomenclature 

Committee for Factors of the HLA 

System.’’ The finalized regulation text at 

newly redesignated § 493.1278(b)(1) 

incorporates this change and is shown 

in its entirety in the final regulatory 

text. 

At § 493.1278(b), we proposed to 

redesignate the provisions at paragraph 

(b)(4) to paragraph (b)(1). At newly 

redesignated paragraph (b)(1), we 

proposed deleting the language that 

states potential new antigens not yet 

approved by this committee must have 

a designation that cannot be confused 

with WHO terminology because new 

alleles are approved monthly, which 

makes this requirement obsolete. 

At § 493.1278(b)(5)(i) through (iv), we 

proposed deleting the requirements for 

preparation of cells or cellular extracts, 

selecting typing reagents, ensuring that 

reagents used for typing are adequate, 

and assignment of HLA antigens as they 

are already addressed by the general 

requirements for all test systems under 

§§ 493.1445(e)(1) and (e)(3)(i), 493.1251, 

and 493.1252, and therefore, are 

duplicative. 

At § 493.1278(b)(5)(v), we proposed to 

modify the requirement to add ‘‘allele’’ 

and delete the ‘‘re’’ prefix in the word 

‘‘retyping’’ in this paragraph and to 

redesignate the provisions at paragraph 

(b)(5)(v) to paragraph (b)(2). We 

proposed inserting ‘‘allele’’ because the 

regulation only has antigen typing, but 

there is typing done at the allele level. 

We proposed deleting the ‘‘re’’ prefix to 

remove redundancy under the proposed 

revision at § 493.1278(b)(2) which 

requires the laboratory to have written 

criteria to define the frequency for 

performing typing. 

At § 493.1278(b)(6)(i) through (iii), we 

proposed deleting requirements for HLA 

typing control materials procedures as 

they are addressed by the general 

requirements regarding quality control 

materials and procedures for all test 

systems under § 493.1256(a) through (d) 

and (f) through (h), and therefore, are 

duplicative. 

At § 493.1278(c), we proposed 

deleting this requirement for control 

procedures and materials regarding 

disease related studies because this is 

addressed by the general requirements 

for all test systems under §§ 493.1256(d) 

and 493.1451(b)(4), and therefore, is 

duplicative. 

At § 493.1278(d), we proposed 

changing the name of this section from 

‘‘Antibody Screening’’ to ‘‘Antibody 

Screening and Identification’’ for 

clarification as both processes apply to 

histocompatibility testing. The 

provisions covered under this section 

apply to both screening and 

identification. We proposed moving 

§ 493.1278(d) as revised to 

§ 493.1278(c). 

At § 493.1278(d)(1) through (3) and (5) 

through (7), we proposed deleting these 

requirements for antibody screening 

laboratory procedures as they are 

addressed by the general requirements 

for all test systems under 

§§ 493.1445(e)(1) and (e)(3)(i), 493.1251, 

493.1252, and 493.1256, and therefore, 

are duplicative. 

We received public comments on 

these proposals at § 493.1278(a) through 

(d). The following is a summary of the 

public comments we received and our 

responses. 

Comment: A commenter supported 

the modification under § 493.1278(a)(1) 

requiring the use of a continuous 

monitoring system and alert system to 

monitor the storage temperature of 

specimens but added that this may 

result in an additional burden for 

smaller laboratories with limited funds. 

Response: Many continuous 

monitoring systems have alerts built 

into the system. Laboratories can also 

develop policies and procedures for an 

alert system built upon the results of the 

continuous monitoring system. We 

believe that the risk associated with the 

incorrect storage temperature of 

specimens and reagents warrants the 

requirement for an alert system. 

Comment: A commenter proposed 

new language for existing standards at 

§ 493.1278(d)(1) to ‘‘use a technique that 

detects HLA-specific antibody that is 

equivalent or superior to the solid phase 

assays’’ and § 493.1278(d)(3) to ‘‘use a 

panel composition that contains all 

major HLA specificities’’ to remain in 

alignment with the United Network for 

Organ Sharing (UNOS) requirements. 

Response: In the proposed rule, we 

proposed to delete § 493.1278(d)(1) and 

(d)(3) as we believe they are addressed 

by the general requirements for all test 

systems under §§ 493.1445(e)(1) and 

(e)(3)(i), 493.1251, 493.1252, and 

493.1256. LDs can choose to implement 

UNOS requirements as part of their 

responsibilities indicated under 

§ 493.1445(e)(3)(i). Therefore, we are not 

making any language change and are 

finalizing the proposed deletion of 

§ 493.1278(d)(1) and (d)(3). 

Comment: A commenter suggested the 

inclusion of current § 493.1278(d)(5) 

‘‘have available and follow a written 

policy consistent with clinical 

transplant protocols for the frequency of 

screening potential transplant 

beneficiary sera for preformed HLAspecific antibodies.’’ 

Response: We believe the general 

requirements for all test systems under 

§ 493.1251 address the requirement for 

laboratories to have available and follow 

written policies. Therefore, we are 

finalizing the proposed deletion of 

§ 493.1278(d)(5). 

Comment: Several commenters 

suggested the removal of the word 

‘‘serologic’’ in the proposed language for 

crossmatching at § 493.1278(d)(2)(iv) to 

account for allele-specific antibody 

detection. Another commenter stated 

that serologic typing is insufficient for 

current clinical histocompatibility 

testing due to its many limitations, 

including low specificity at certain loci 

and the potential for certain false 

negative results, and suggested changing 

the language to ‘‘typing of the donor by 

molecular methods at the serologic split 

antigen equivalent.’’ 

Response: We agree with the 

commenters that removing ‘‘serologic’’ 

will maintain flexibility with the 

evolution of testing practices. We are 

not specifying molecular methods, but 

instead, are modifying our proposed 

revisions to remove reference to the 

‘‘serologic’’ level at revised 

§ 493.1278(d)(2)(iv). 

We received no comments on 

proposed § 493.1278(a)(2) through (4) 

and (c) and are finalizing these 

provisions as proposed. 

After consideration of the comments 

received, we are finalizing the proposed 

changes at § 493.1278(a) through (d), 

with the following modifications to the 

proposed revisions at (b)(1) and 

(d)(2)(iv): 

• To update the regulation at 

redesignated § 493.1278(b)(1) to 

incorporate the revised name of the 

World Health Organization (WHO) 

committee that determines HLA 

nomenclature, ‘‘Nomenclature 

Committee for Factors of the HLA 

System.’’ 

• To finalize the proposed revisions 

at § 493.1278(d)(2)(iv) with 

modification, to remove ‘‘at the 

serologic level’’. 

2. Crossmatching and Transplantation 

(§ 493.1278(e) and (f)) 

At § 493.1278(e)(1) through (3), we 

proposed removing these three 

requirements regarding the laboratory 


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having crossmatch procedures and 

controls as we believe the provisions to 

be removed are addressed by the general 

requirements for all test systems under 

§§ 493.1445(e)(1), 493.1251, 493.1256, 

and 493.1451(b)(4), and therefore, are 

duplicative. 

Since 1992, there have been important 

advances in the field of transplantation 

and histocompatibility. Based on 

comments received in response to the 

2018 RFI and interested parties and 

CLIAC input, we understand the current 

regulations at § 493.1278 do not reflect 

the standard practice for laboratories 

performing testing in the specialty of 

histocompatibility and are viewed by 

the transplantation community as a 

barrier to modernized decision making 

approaches for organ acceptability. 

Additionally, we understand that the 

use of risk assessment and alternative 

immunologic assessment procedures are 

currently the standard practice for 

laboratories performing testing in the 

specialty of histocompatibility. 

Therefore, we proposed to add the 

requirements summarized below, at 

§ 493.1278(d), to increase flexibility in 

the regulations and remove perceived 

barriers. These requirements include: 

• Defining donor and recipient HLA 

antigens, alleles, and antibodies to be 

tested; 

• Defining the criteria necessary to 

assess a recipient’s alloantibody status; 

• Assessing recipient antibody 

presence or absence on an ongoing 

basis; 

• Typing the donor at the serological 

level, to include those HLA antigens to 

which antibodies have been identified 

in the potential recipient, as applicable; 

• Describing the circumstances in 

which a pre- and post-transplant 

confirmation testing of donor and 

recipient specimens is required; 

• Making available all applicable 

donor and recipient test results to 

transplant team; 

• Ensuring immunologic assessments 

are based on the test report results 

obtained from a test report from CLIA 

certified testing laboratory(ies); 

• Defining time limits between 

recipient testing and the performance of 

crossmatch; and 

• Requiring that the test report must 

specify what type of crossmatch was 

performed. 

At § 493.1278(f), we proposed to 

change the words ‘‘transfusion’’ and 

‘‘transfused’’ to ‘‘infusion’’ and 

‘‘infused’’, respectively. The relevance 

of HLA testing and the decisions of the 

extent of testing in both a transplant and 

transfusion setting are critical to both 

organ and cell acceptance in the host 

recipient. The use of the word 

‘‘transfusion’’ is inappropriate given 

that the product itself is the transfusion 

but the action of introducing the 

product is the process of infusion. 

Transfusion is more specific to 

immunohematology. There are specific 

transfusion regulations in the 

immunohematology section at 

§ 493.1271 that should not be confused 

with histocompatibility requirements. 

Since histocompatibility addresses 

materials that are not always blood 

products, we believe the term 

‘‘infusion’’ would be more appropriate. 

We proposed moving § 493.1278(f) as 

revised to § 493.1278(e). 

At § 493.1278(f)(1), we proposed 

revising this requirement to state that 

laboratories performing 

histocompatibility testing must establish 

and have written policies and 

procedures specifying the types of 

histocompatibility testing. We proposed 

moving this language to § 493.1278(e). 

In addition, we proposed adding 

‘‘identification’’ after ‘‘antibody 

screening’’ in the revised § 493.1278(c), 

as identification is an important part of 

the process for crossmatching. Finally, 

we proposed removing ‘‘compatibility 

testing’’ at § 493.1278(f)(1) because this 

activity is specific to 

immunohematology, and crossmatching 

is a more appropriate description of 

what we understand is the current 

histocompatibility procedure used by 

laboratories. We proposed moving 

§ 493.1278(f)(1) as revised to 

§ 493.1278(e). 

At § 493.1278(f)(1), we further 

proposed modifying the current general 

requirement to specify that the 

laboratory must establish and follow 

written policies and procedures that 

address the transplant type (organ, 

tissue, cell) donor type (living, 

deceased, or paired) and recipient type 

(high risk vs. non-sensitized). The 

following terminologies were also 

updated to reflect current practices: 

‘‘cadaver donor’’ is replaced by 

‘‘deceased donor,’’ ‘‘transfused’’ is 

replaced by ‘‘infused,’’ and ‘‘combined’’ 

is replaced by ‘‘paired.’’ In addition, we 

believe that clarifying the current 

regulatory language allows the 

laboratories to make decisions based on 

existing technologies and practices for 

determining what testing is applicable 

for those transplant programs they 

serve. We proposed moving 

§ 493.1278(f)(1) as revised to 

§ 493.1278(e)(1). 

At § 493.1278(f)(2) through (3), we 

proposed to remove these requirements 

for renal and nonrenal transplantation 

crossmatch procedures which are 

perceived as obstacles to current 

practices by the transplant community 

and instead allow for alternative 

immunologic assessment procedures to 

be used in the designated specialty of 

histocompatibility. The requirements 

that the laboratory must establish and 

follow written policies and procedures 

are already addressed in the general 

requirements for all test systems under 

§§ 493.1445(e)(1) and (e)(3)(i), 493.1251, 

493.1256(c) through (h), and 

493.1451(b)(4) and, therefore, are 

duplicative. In addition, we proposed 

adding a new requirement for pretransplant recipient specimens under 

the proposed § 493.1278(e)(3). Under 

this new proposed requirement, the 

laboratory must have written policies 

and procedures to obtain a recipient 

specimen for a crossmatch, or to 

document its efforts to obtain a recipient 

specimen, collected on the day of 

transplant. We recognize that the 

laboratory may not be able to obtain a 

recipient specimen collected on the day 

of a transplant since this collection 

process depends upon the physician 

obtaining the specimen and submitting 

it to the laboratory. 

At § 493.1278(f)(1)(ii), we proposed 

modifying this requirement for 

laboratory policies and procedures as it 

would be included in the amended 

protocol requirements under the 

proposed regulation at 

§ 493.1278(e)(1)(i) and (iii), and 

therefore, would be duplicative. The 

proposed revised requirement reflects 

current practices in the 

histocompatibility community. 

At § 493.1278(f)(1)(iii), we proposed 

replacing ‘‘the level of’’ with ‘‘type and 

frequency’’ to clarify this revised 

requirement refers to the type and 

frequency of testing practice to support 

the clinical transplant protocols. We 

also proposed removing the examples of 

antigen and allele level in the regulation 

as these examples may not be allinclusive and generally are reflected in 

guidance rather than regulatory text. We 

proposed redesignating 

§ 493.1278(f)(1)(iii) as § 493.1278(e)(2). 

The requirement at § 493.1278(g) 

would be redesignated as § 493.1278(f). 

This requirement remains unchanged. 

We received public comments on 

these proposals at § 493.1278(e) through 

(f). The following is a summary of the 

public comments we received and our 

responses. 

Comment: Several commenters stated 

that virtual crossmatch is an 

immunologic assessment, not a test. One 

of the commenters added that a ‘‘test’’ 

requires a specific procedure to be 

performed, and virtual crossmatches are 

often assessments of existing candidate 

and donor test results to determine 

potential immunologic compatibility or 


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the need for additional testing to occur. 

The commenters suggested modification 

of the proposed language at 

§ 493.1278(d)(3) and § 493.1278(e) to 

include immunologic assessment 

language. 

Response: The CLIA regulations refer 

to ‘‘test’’ and ‘‘test systems,’’ and do not 

refer to ‘‘immunologic assessment.’’ We 

believe this would cause confusion by 

introducing a new term to the 

regulations without defining the term. 

Therefore, we will incorporate 

information related to immunologic 

assessment in updated guidance related 

to § 493.1278(d)(3) and § 493.1278(e). 

Comment: Several commenters 

requested clarification of the proposed 

new requirement for pretransplant 

recipient specimens at § 493.1278(e)(3). 

Another commenter questioned if the 

proposed requirement means that (1) 

laboratories must obtain a specimen on 

the day of the transplant or document 

the attempts made to obtain a specimen 

on the day of the transplant, or (2) 

laboratories must collect a specimen on 

the day of the transplant or have 

documentation of attempts to obtain 

such a specimen, but documentation 

could be after the day of the transplant. 

The second commenter requested 

additional clarity around the intended 

use of the proposed recipient specimen 

for crossmatch to be obtained on the day 

of the transplant and what the required 

use of that sample would be, adding that 

the laboratory and clinical team should 

be able to define how current a sample 

must be for candidate testing, as already 

required in the proposed 

§ 493.1278(d)(2)(viii). The commenter 

believes the laboratory and clinical team 

should be able to assess the need for an 

updated sample after considering 

timing, potential sensitizing events, and 

previous candidate alloantibody levels 

and that it may not be necessary to draw 

an additional recipient specimen in all 

cases. The same commenter requested 

flexibility on pre-transplant samples 

drawn for young pediatric candidates, 

stating that the small size of some 

pediatric candidates can make 

additional blood volume drawn 

immediately pre-transplant harmful. 

Response: As explained in the 

proposed rule, we recognize that the 

laboratory may not be able to obtain a 

recipient specimen collected on the day 

of a transplant since this collection 

process depends upon the physician 

obtaining the specimen and submitting 

it to the laboratory. Therefore, we 

proposed at § 493.1278(e)(3) that the 

laboratory has a process to obtain a 

recipient specimen, if possible, for 

crossmatch collected on the day of the 

transplant. If the laboratory cannot 

obtain a recipient specimen on the day 

of the transplant, it must have a process 

to document its efforts to obtain the 

specimen. The laboratory 

documentation does not have to be on 

the day of the transplant but could be 

after the day of the transplant. In this 

final rule, we are also adding 

clarification at § 493.1278(e)(3) that the 

recipient specimen be collected prior to 

transplantation on the day of the 

transplant. Also, as proposed under 

§ 493.1278(e), laboratories must 

establish and follow written policies 

and procedures specifying the 

histocompatibility testing to be 

performed for each type of cell, tissue, 

or organ to be infused or transplanted. 

The laboratory or clinical team must 

have policies and procedures in place to 

define when there is a need for 

additional recipient specimens for 

immunologic assessment and the 

circumstances when the collection of 

additional recipient specimens is not 

needed, such as in pediatric cases. The 

laboratory is allowed flexibility to 

determine its policies and procedures 

under proposed revised 

§§ 493.1278(e)(3) and 493.1251. 

After consideration of the comments 

received, we are finalizing the proposed 

changes at § 493.1278(e) and (f), with 

modification to the proposed revisions 

at § 493.1278(e)(3) related to the 

laboratory process to obtain a recipient 

specimen, if possible, for crossmatch 

collected on the day of the transplant 

and prior to transplantation. 

B. Changes to Personnel Requirements 

We stated in the proposed rule that 

CMS recognizes that the COVID–19 

public health emergency (PHE) requires 

flexibility, and that we are committed to 

taking critical steps to ensure America’s 

clinical laboratories can respond during 

a PHE to provide reliable testing while 

ensuring patient health and safety. As 

such, we requested that the public 

provide comments regarding how the 

CLIA personnel requirements in subpart 

M have affected the health system’s 

response to the COVID–19 PHE and any 

potential opportunities for improvement 

to such requirements. We welcomed 

suggestions regarding potential 

improvements that may be specific to a 

pandemic or PHE context, as well as 

broader recommendations. 

1. Definitions (§ 493.2) 

a. Mid-Level Practitioner 

At § 493.2, we proposed amending the 

definition of midlevel practitioner by 

adding a nurse anesthetist and clinical 

nurse specialist to the definition. CLIA 

currently defines a midlevel practitioner 

as a nurse midwife, nurse practitioner, 

or physician assistant. We stated in the 

proposed rule that we agree with 

CLIAC’s recommendation to include 

nurse anesthetists and clinical nurse 

specialists in the definition of midlevel 

practitioner. We believe including nurse 

anesthetists and clinical nurse 

specialists in the definition will be 

inclusive of current types of mid-level 

practitioners. For example, the 

American Association of Nurse 

Anesthetists 17 scope of practice states 

that the practice may include 

performing point-of-care testing. 

We received public comments on this 

proposed definition. The following is a 

summary of the comments we received 

and our responses. 

Comment: A commenter expressed 

concern about updating the midlevel 

practitioner definition to include 

registered nurse anesthetists and 

clinical nurse specialists to be 

considered mid-level practitioners in 

the laboratory testing scope. The 

commenter noted that MTs have more 

courses designed to prepare them to 

work in a laboratory setting as compared 

to nursing students. 

Response: The definition of a 

midlevel practitioner only applies to a 

site with a Certificate for Providerperformed Microscopy Procedures. PPM 

procedures, as described under § 493.19, 

are a select group of moderately 

complex microscopic tests that do not 

meet the criteria for waiver because they 

are not simple procedures; they require 

training and specific skills for test 

performance, and they must meet 

certain other standards. Since these 

procedures are performed at the time of 

a physician office visit, including 

registered nurse anesthetists and 

clinical nurse specialists as part of the 

definition of a midlevel practitioner 

allows greater access to PPM testing. 

The curriculum for the midlevel 

practitioners including RNAs and CNSs 

covers this type of testing. 

After consideration of public 

comments, we are finalizing the 

proposed definition of ‘‘midlevel 

practitioner.’’ 

b. Continuing Education (CE) Credit 

Hours 

At § 493.2, we proposed adding a 

definition for ‘‘Continuing education 

(CE) credit hours’’ to state that it means 

either continuing medical education 

(CME) or CE units. Generally, CME 

refers to continuing education credits 

earned by physicians (by which we 

mean doctors of medicine, osteopathy, 

or podiatric medicine). We proposed 


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that CE would be a broader term used 

for individuals seeking to qualify as LDs 

who are not physicians. We noted that 

in the current CLIA regulations at 

§ 493.1405(b)(2)(ii), CME is considered 

as acceptable training or experience for 

individuals to qualify as a LD 

overseeing moderate complexity testing. 

We stated in the proposed rule that 

because we were proposing in section 

III.B. of the proposed rule to require all 

individuals seeking to qualify as a LD 

for both moderate and high complexity 

testing to have 20 CE credit hours, we 

believed we needed to establish a more 

general term for purposes of the 

proposed requirement. As described 

below, the CE credit hours would cover 

all of the LD responsibilities defined in 

the applicable regulations and must be 

obtained prior to qualifying as a LD. For 

example, we proposed at 

§ 493.1405(b)(2)(ii)(B), the 20 CE credit 

hours would be required to cover all of 

the LD responsibilities defined in 

§ 493.1407 (moderate complexity 

testing). 

The term CME was originally used 

because it was only required at 

§ 493.1405(b)(2)(ii)(B), which is a 

provision specifically related to doctors 

of medicine, osteopathy, or podiatry. 

We believe that including a definition 

for CE credit hours in the CLIA 

regulations will respect that historic 

use, afford a means of referring to a 

broader range of professionals who may 

qualify as LDs, and alleviate confusion 

between the terms. 

We received public comments on this 

proposed definition. The following is a 

summary of the comments we received 

and our responses. 

Comment: A commenter noted that 

organizations provide CME for 

physicians that the Accreditation 

Council for Continuing Medical 

Education (ACCME) approves as CME 

providers. The commenter stated that 

CME programs are subject to strict rules 

about conflict of interest, commercial 

interests, and course design, which 

includes learning objectives. The 

commenter suggested that the definition 

of CE credit hours be modified to meet 

equivalent or similar standards as CME. 

Response: The proposed definition of 

CE credit hours under § 493.2 includes 

CME as a CE option. As previously 

discussed, the term CME was originally 

used because it was only required at 

§ 493.1405(b)(2)(ii)(B), which is a 

provision specifically related to doctors 

of medicine, osteopathy, or podiatry. 

We proposed and are now finalizing a 

continuing education requirement for 

non-physician LDs who do not have an 

earned doctoral degree in biology, 

chemistry, clinical or medical laboratory 

science or medical technology. Because 

the term CME generally refers only to 

continuing education credits earned by 

physicians, we are finalizing a broader 

term, CE, which is defined to include 

either CME or CEUs. CLIA regulations 

do not regulate either CME or CE 

providers regarding conflict of interest, 

commercial interests, and course design, 

which includes learning objectives. 

CLIA regulations do however require 

that to be qualified as an LD, the 

candidate must obtain CME credits, or 

under this final rule CE credits, which 

cover all of the LD responsibilities 

defined in the applicable regulations. 

After consideration of public 

comments, we are finalizing the 

proposed definition of ‘‘continuing 

education (CE) credit hours’’ without 

modification. 

c. Doctoral Degree 

At § 493.2, we proposed adding a 

definition for ‘‘doctoral degree’’ to state 

that it means an earned postbaccalaureate degree with at least 3 

years of graduate level study that 

includes research related to clinical 

laboratory testing or advanced study in 

clinical laboratory science or medical 

technology. Originally, degrees were 

given in medical technology; however, 

the naming convention for medical 

technology degrees has changed since 

the regulations were first published in 

the February 1992 final rule with 

comment period. We stated in the 

proposed rule that the degree is now 

referred to as clinical laboratory science 

and that a clinical laboratory science 

degree is synonymous with a medical 

technology degree. For purposes of 42 

CFR part 493, doctoral degrees would 

not include doctors of medicine (MD), 

doctors of osteopathy (DO), doctors of 

podiatry, doctors of veterinary medicine 

(DVM), or honorary degrees. 

We proposed this modification to 

CLIA regulations to clarify what we 

mean by the term ‘‘doctoral degree.’’ It 

seems this general term has created 

confusion as various interested parties 

have inquired about the following. 

• Are doctors of medicine degrees 

considered to be a type of doctoral 

degree? 

• Does a doctoral degree include 

traditional (for example, Doctor of 

Philosophy (Ph.D.), doctorate in science 

(DSc) and professional (for example, 

Doctorate in Clinical Laboratory Science 

(DCLS)) degrees or does doctoral degree 

only mean a Ph.D.? 

The CLIA regulations for personnel 

qualifications separate doctors of 

medicine, osteopathy, and podiatry 

from other non-medical doctoral degrees 

by including specific qualification 

requirements for these three types of 

degrees. MD and DO degrees pertain to 

post-graduate level education, 

specifically in medicine, and are 

associated with treating illnesses and 

medical conditions. In contrast, doctoral 

degrees can be obtained in various fields 

like biology and chemistry. Historically, 

we intended a doctoral degree to mean 

a Ph.D. in a science field related to 

laboratory work. However, we have 

come to understand that our doctoral 

degrees could be interpreted more 

broadly to include both traditional and 

professional doctoral degrees. Doctoral 

degree is a general term used to describe 

post-graduate level education for 

various non-medical specific degrees 

and includes both traditional (for 

example, Ph.D., DSc) and professional 

(for example, DCLS) degrees. A 

traditional earned doctoral degree is 

generally focused on research and may 

include academic coursework and 

professional development. In contrast, a 

professional earned doctoral degree 

emphasizes specific skills and 

knowledge for success in a particular 

profession without a concentrated focus 

on research. For example, the DCLS is 

an advanced professional doctorate 

designed for practicing clinical 

laboratory scientists (CLSs) or medical 

technologists (MTs) who have at least a 

bachelor’s degree and wish to further 

their level of clinical expertise and 

develop leadership and management 

skills. Individuals with a DCLS are 

experts in clinical laboratory testing. 

Individuals must have a bachelor’s 

degree in medical technology or clinical 

laboratory science and the requisite 

experience in order to be admitted to a 

DCLS graduate program. The DCLS 

contributes to increasing laboratory 

efficiency and improves timely access to 

accurate and appropriate laboratory 

information. A graduate of a DCLS 

program will be able to: provide 

appropriate test selection and 

interpretation of test results; monitor 

laboratory data and testing processes; 

improve the quality, efficiency, and 

safety of the overall diagnostic testing 

process; and direct laboratory 

operations to comply with all State and 

Federal laws and regulations. We would 

consider a DCLS an acceptable doctoral 

degree. 

For the purposes of qualifying under 

the CLIA personnel regulations, we do 

not consider a MD or DO to be the same 

as a non-medical doctoral degree. 

Therefore, these individuals must 

continue to qualify under the applicable 

CLIA personnel regulations, that is, MDs 

and DOs must qualify under doctors of 

medicine or osteopathy requirements. 


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som107c06pdf.pdf. 

Those individuals with non-medical 

doctoral degrees as outlined previously 

in this final rule must qualify under the 

doctoral degree requirements. We stated 

in the proposed rule that if finalized, the 

State Operations Manual (SOM) 18 will 

be updated accordingly. 

The CLIA regulations aim to ensure 

accurate and reliable testing on 

specimens derived from the human 

body for the purposes of providing 

information for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

health of human beings. Therefore, we 

stated in the proposed rule that we 

believe that DVM should be removed 

from the qualifying doctoral degrees as 

it is not relevant to testing on specimens 

derived from the human body. We 

understand many of the methodologies 

may be the same; however, testing on 

human specimens is clearly specified in 

the statutory language and regulatory 

definition of a laboratory under CLIA. 

Therefore, testing of animal specimens 

does not meet the intent of the CLIA 

regulations. Of the nine boards 

approved by HHS for qualification of 

applicants with doctoral degrees, only 

one allows individuals with DVMs to sit 

for board certification. Since 1965, 

American Board of Medical 

Microbiology has granted certification to 

four individuals. We stated that 

individuals who have previously 

qualified under a provision requiring a 

doctoral degree will continue to qualify 

under the new rule, if finalized. We 

further stated that if finalized, we would 

remove the reference to DVMs in the 

SOM, Chapter 6 (that is, Interpretive 

Guidelines) under § 493.1443(b)(3) (page 

353). 

Finally, as discussed previously in 

this rule, we proposed that a doctoral 

degree must be an earned postbaccalaureate degree with at least 3 

years of graduate level study that 

includes research related to clinical 

laboratory testing or advanced study in 

clinical laboratory science or medical 

technology. As such, honorary degrees 

do not meet the intent of a qualifying 

doctoral degree as an individual has not 

completed the necessary course and 

laboratory work required for the postbaccalaureate degree or necessary to 

ensure quality testing, for example, 

accurate and reliable results. We believe 

that qualifying individuals who hold 

only honorary degrees is not consistent 

with the public health purposes of the 

CLIA statute. Furthermore, we believe 

that this would impede CMS’ ability to 

ensure health and safety of the public 

and individuals served by CLIAcertified laboratories. 

We received public comments on this 

proposed definition. The following is a 

summary of the comments we received 

and our responses. 

Comment: Several commenters 

referenced the 2022 decision by the 

American Medical Technologists 

(AMT), ASCP, and the American 

Society for Clinical Laboratory Science 

(ASCLS) to change the MT certification 

designation to Medical Laboratory 

Scientist (MLS). The commenters stated 

that this change recognizes the 

specialized expertise that the medical 

laboratory scientist brings to the 

practice of healthcare diagnostics, 

which needs to be adequately reflected 

in the term ’technologist.’ The 

commenters suggested that medical 

laboratory science should be used in 

addition to clinical laboratory science in 

the proposed definition of doctoral 

degree under § 493.2. 

Response: We agree with the 

commenters that medical laboratory 

science should be included in the 

definition of a doctoral degree, aligning 

with the 2022 decision to rename MT to 

MLS to elevate the visibility of the 

laboratory field. As a result, we have 

incorporated the change suggested by 

the commenters to include medical 

laboratory science in addition to clinical 

laboratory science in the finalized 

definition of doctoral degree at § 493.2, 

and elsewhere in these finalized 

regulations, where applicable, as 

discussed later in this final rule. 

Comment: A commenter expressed 

concern about the proposed definition 

of a doctoral degree, stating that many 

LDs with Ph.D. degrees come from a 

basic science background. These degrees 

require laboratory experience, yet that 

experience may not be related to clinical 

laboratory testing or clinical laboratory 

science. The commenter stated that 

qualification to direct a clinical 

laboratory is ensured by requiring board 

certification. The commenter believed 

that limiting permissible doctoral 

degrees to those relating directly to 

medical or clinical laboratory science 

would eliminate the vast majority of the 

candidate pools many fellowship 

programs draw from. 

Response: We disagree with the 

commenter. The revised LD 

qualifications for moderate (§ 493.1405) 

and high (§ 493.1443) complexity testing 

expand the LD candidate pool in two 

ways. One, while we have removed 

physical science as a qualifying degree, 

we are adding two new degree types: 

medical laboratory science and medical 

technology. Two, if individuals hold 

non-qualifying degrees, they now have 

the opportunity to qualify under the 

new educational pathways. The CLIA 

regulations ensure accurate and reliable 

testing on specimens derived from the 

human body for the purposes of 

providing information for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

health of human beings. We believe that 

the inclusion of research related to 

clinical laboratory testing or advanced 

study in clinical laboratory science, 

medical laboratory science, or medical 

technology in the doctoral degree 

definition, as well as the additional 

educational option, encompasses the 

need to ensure that LDs complete the 

required course and laboratory work to 

ensure quality testing for accurate and 

reliable results. 

Comment: Several commenters 

disagreed with the proposed removal of 

the DVM degree from the qualifying 

doctoral degrees. Commenters stated 

that during the COVID–19 PHE, 

veterinary diagnostic laboratories 

(VDLs) were a significant resource 

capable of conducting critical public 

health diagnostic and surveillance 

testing. The commenters stated that 

VDLs conducted millions of tests that 

might otherwise not have been run. 

Commenters further stated that in some 

States, the VDL response capability and 

capacity served as the primary COVID– 

19 testing resource. However, they 

asserted that incorporating this valuable 

resource into the PHE response was 

often significantly delayed due to the 

inflexibility regarding recognizing VDL 

staff’s training, knowledge, and 

experience as equal to that mandated 

under CLIA. Another commenter 

indicated that directors of VDLs are 

board certified in their specialties and 

often have Ph.D.s in addition to their 

DVMs. There were additional 

commenters that supported the removal 

of a DVM degree from the qualifying 

doctoral degrees. 

Response: Based on the critical role 

veterinary facilities provided in rapidly 

increasing testing capacity during the 

COVID–19 PHE, we believe it is 

appropriate to include DVMs during 

PHEs and may consider extending that 

flexibility in future PHEs. However, for 

the reasons previously discussed, these 

degrees would not be included as 

qualifying doctoral degrees outside of a 

PHE. Personnel with DVM degrees may 

qualify through the other routes 

indicated in subpart M. In addition, any 

individual with a DVM who is qualified 

and employed as an LD as of the 

effective date of this final rule will be 

grandfathered and continue to qualify as 

outlined in the grandfather provisions 


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discussed elsewhere in this final rule, 

provided the individual remains 

continuously employed as an LD after 

the effective date. 

After consideration of public 

comments, we are finalizing the 

proposed definition of ‘‘doctoral 

degree’’, with modification to include 

medical laboratory science. We are also 

modifying ‘‘doctors of podiatry’’ to 

‘‘doctors of podiatric medicine (DPM)’’ 

to be consistent with current 

regulations. 

d. Training and Experience 

At § 493.2, we proposed to add a 

definition for ‘‘Laboratory training or 

experience’’ to state that it means that 

the training or experience must be 

obtained in a facility that meets the 

definition of a laboratory under § 493.2 

and is not excepted from CLIA under 

§ 493.3(b). Laboratory subject to CLIA 

would mean the laboratory meets the 

definition of a ‘‘laboratory’’ under 

§ 493.2. Training and experience 

obtained in a research laboratory that 

only reports aggregate results or a 

forensic laboratory does not meet this 

definition. These types of facilities are 

exempt from CLIA under § 493.3(b), and 

as such, training and experience 

acquired in these facilities is not 

applicable to CLIA laboratories. 

In all situations, an individual is 

required to meet training and/or 

experience requirements in addition to 

the educational requirements to 

competently perform their regulatory 

responsibilities. Because the CLIA 

personnel requirements for nonwaived 

testing are based on the complexity of 

testing performed (moderate versus 

high), we concluded that appropriate 

training and experience is necessary. 

Comments from the 2018 RFI support 

this proposal. Comments received from 

the 2018 RFI include the following: 

• Training and or experience should 

be in a CLIA certified laboratory. 

• Research experience is not 

equivalent to clinical experience. 

• Dependent on complexity level of 

testing, minimum standards should 

increase as the complexity level 

increases. 

Further, commenters stated that 

documentation from a former employer 

would be acceptable, provided it 

included specific details of the 

individual’s job description, training 

and competency assessment (CA) for 

areas of testing performed. This 

documentation could be from an LD, 

manager or supervisor. 

We concur with the CLIAC 

recommendation, and comments from 

the 2018 RFI that all personnel should 

have training and experience in their 

areas of responsibility as listed in CLIA 

for the appropriate test complexity as 

shown in Table 8, which shows the 

specific personnel categories that have a 

provision requiring training or 

experience, or both, or require 

experience directing or supervising, or 

both. 

This means personnel should have 

training or experience examining and 

performing tests on human specimens 

for the purpose of providing information 

that is used in diagnosing, treating, and 

monitoring an individual’s condition. 

Each individual must have 

documentation of training or experience 

applicable to the types and complexity 

of testing performed. This training 

should be such that the individual can 

demonstrate that he or she has the skills 

required for the proper performance of 

pre-analytic, analytic, and post-analytic 

phases of testing. For example, if the 

individual performs blood gas testing on 

a nonwaived point of care device, 

demonstration of skills should include, 

but is not limited to, the following: 

• Proper specimen collection, 

handling and labelling; 

• Proper test performance according 

to the laboratory’s policies and 

manufacturer’s instructions; 

• Verification of performance 

specifications; 

• Calibration and preventive 

maintenance; 

• Proficiency testing; and 

• Proper reporting of patient test 

results. 

Training may include, but is not 

limited to, attendance at: 

• Seminars given by experts in the 

field; 

• On-site or off-site instrument 

trainings given by a manufacturer; 

• Technical training sessions, 

workshops, or conferences given by a 

professional laboratory organization; or 

• A formal laboratory training 

program. 

Documentation may consist of, but is 

not limited to: 

• Letters from training programs or 

employers; 

• Attestation statements of an 

individual’s training and experience by 

the LD; 

• Log sheet(s) initialed by the 

attendees indicating attendance at a 

training session or in-service; and 

• Certificates from organizations 

providing the training session, 

workshop, conference, specialty course. 

We expect all documentation 

supporting an individual’s education, 

training and experience to be 

independently generated, that is, not 

authored by the individual who is trying 

to meet CLIA personnel qualification 

requirements. For example, a 

curriculum vitae (CV) is not acceptable 

verification, in and of itself, to 

document an individual’s education, 

training or experience. Letters on 

letterhead from previous employment, 

competency assessment, and 

comprehensive list of job 

responsibilities may be examples of 

acceptable documentation. 

Laboratory testing of non-human 

specimens is not acceptable experience, 

for example, environmental, animal 

testing, as it is not used for the purpose 

of providing information used in the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 


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TABLE 8: Personnel Requirements by Test Complexity for Proposed Personnel Changes 

that Require Training or Experience, or Both 

CLIASection Role Complexity 

§ 493.1405 Laboratory director Moderate 

§ 493.1411 Technical consultant Moderate 

§ 493.1423 Testing personnel Moderate 

§ 493.1443 Laboratory director High 

§ 493.1449 Technical supervisor Hicll 

§ 493.1489 Testing personnel High 
90002 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

19https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/ResearchTesting-and-CLIA.pdf. 20https://www.govinfo.gov/content/pkg/USCODE2011-title42/pdf/USCODE-2011-title42-chap6AsubchapII-partF-subpart2-sec263a.pdf. 

assessment of the health of, human 

beings. 

Comments received on the 2018 RFI 

stated that experience from a research 

laboratory should not be accepted. 

Depending on the circumstances, 

research testing can be either exempt 

from CLIA or subject to CLIA. 

Specifically, research laboratories that 

test human specimens but do not report 

patient specific results for the diagnosis, 

prevention or treatment of any disease 

or impairment of, or the assessment of 

the health of individual patients, are 

excepted from the CLIA regulations at 

§ 493.3(b)(2). In accordance with that 

regulation, only those facilities 

performing research testing on human 

specimens that do not report patientspecific results may qualify to be 

exempt from CLIA certification.19 An 

example of a non-patient-specific result 

would be ‘‘10 out of 30 participants 

were positive for gene X.’’ The result in 

this example is a summary of the group 

data and is not indicative of an 

individual’s health. An example of a 

patient—specific result would be 

‘‘participant A was positive for gene X’’ 

in which the result is specific to 

participant A. In cases where patientspecific test results are maintained by a 

statistical research center for possible 

use by investigators in which the results 

are not reported out as patient-specific 

and could not be used ‘‘for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of the health of, human 

beings,’’ CLIA would not apply. 

Research testing where patientspecific results are reported from the 

laboratory, and those results will be or 

could be used ‘‘for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

the health of, human beings’’ are subject 

to CLIA. Therefore, we would consider 

research experience related to reporting 

patient-specific results as applicable 

experience to meet the CLIA personnel 

requirements; however, if the research 

experience only included aggregate 

reporting of results, we would not 

consider this acceptable experience to 

meet CLIA personnel requirements as 

this type of research testing is exempt 

from CLIA (§ 493.3(b)(2)). 

CLIA regulations at § 493.3(b)(1) 

specifically exempt facilities or 

components of facilities that only 

perform testing for forensic purposes 

from CLIA requirements. This was 

addressed in a Survey and Certification 

policy memo (S&C–08–35) published on 

September 5, 2008 (https://

www.cms.gov/Medicare/ProviderEnrollment-and-Certification/ 

SurveyCertificationGenInfo/Policy-andMemos-to-States-and-Regions.html). 

(See the preamble to the February 1992 

final rule with comment period for an 

important discussion concerning this 

subject (57 FR 7014)). 

In summary, laboratory results 

generated purely for the purpose of 

detecting illegal substances or illegal 

amounts of certain substances in the 

body may be relevant to legal 

proceedings. However, there is no 

concern in such testing for developing 

accurate and reliable data for use by 

health care professionals for the purpose 

of diagnosis or treatment. The 

determining factor is not the test itself, 

but the purpose for which the test is 

conducted. 

In addition, based on the CLIA law, 

forensic testing is excluded under CLIA 

since forensic testing is conducted to 

determine if there has been a violation 

of the law and is not done for the 

purpose for providing diagnosis, 

treatment or assessment of health. 

Therefore, we do not consider 

forensic testing to be an acceptable 

experience or training to meet CLIA 

personnel requirements as this type of 

testing is exempt from CLIA 

(§ 493.3(b)(3)). 

We received public comments on this 

proposed definition. The following is a 

summary of the comments we received 

and our responses. 

Comment: A commenter suggested 

expanding the definition of laboratory 

training or experience to allow research 

staff to qualify as laboratory testing 

personnel. 

Response: The CLIA statute 20 defines 

a laboratory as a facility for the 

biological, microbiological, serological, 

chemical, immuno-hematological, 

hematological, biophysical, cytological, 

pathological, or other examination of 

materials derived from the human body 

for the purpose of providing information 

for the diagnosis, prevention, or 

treatment of any disease or impairment 

of, or the assessment of the health of, 

human beings. Laboratories that are 

performing research only (and do not 

report patient specific results for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of the health of, human 

beings) are not subject to CLIA 

regulations. Personnel with experience 

in a research laboratory may qualify 

under the methods listed under CLIA 

subpart M—Personnel for Nonwaived 

Testing. 

After consideration of public 

comments, we are finalizing the 

proposed definition of ‘‘laboratory 

training or experience’’ without 

modification. 

e. Experience Directing or Supervising 

At § 493.2, we proposed adding a 

definition for ‘‘Experience directing or 

supervising’’ to state that it means that 

the director or supervisory experience 

must be obtained in a facility that meets 

the definition of a laboratory under 

§ 493.2 and is not excepted under 

§ 493.3(b). Experience directing or 

supervising a research laboratory that 

tests human specimens but does not 

report patient-specific results for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of the health of individual 

patients would not meet this definition 

(for example, reporting of aggregate 

results). Experience directing or 

supervising any facility or component of 

a facility that only performs testing for 

forensic purposes also would not meet 

this definition. The ordering of tests and 

interpreting and applying the results of 

these tests in diagnosing and treating an 

individual’s illness would not meet this 

definition because it is not related to the 

performance of clinical laboratory 

testing. Ordering of tests and 

interpreting and applying of results falls 

under the practice of medicine and are 

not related to the performance of 

clinical laboratory testing. Teaching 

experience directly related to a medical 

technology or clinical laboratory 

sciences program, or a clinical 

laboratory section of a residency 

program, would be considered 

acceptable experience because we 

understand that such experience from 

teaching related to a medical technology 

or clinical laboratory sciences program 

would include all aspects of the entire 

testing process (pre-analytic, analytic 

and post-analytic), as well as quality 

control and quality assessment. These 

are critical responsibilities of a LD as 

defined by CLIA. See discussion on 

proposed definition of ‘‘Laboratory 

training or experience’’ for more 

information on proposed treatment of 

research laboratories and forensic 

testing experience. 

We did not receive public comments 

on this proposed definition for 

‘‘Experience directing or supervising’’ 

and are finalizing as proposed. 

2. PPM Laboratory Director 

Responsibilities (§ 493.1359) 

At § 493.1359, we proposed clarifying 

the competency assessment (CA) 


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requirements for PPM laboratories in the 

Standard for PPM LD responsibilities, as 

this testing is moderate complexity per 

§ 493.19(b)(2) and subject to CA. Based 

on the fact the regulations do not have 

a requirement for a TC for PPM 

laboratories, we believe that it is 

currently unclear in the regulation how 

CA applies to these types of 

laboratories. The SOM, Appendix C 

(that is, Interpretive Guidelines) on page 

151 (https://www.cms.gov/Regulationsand-Guidance/Guidance/Manuals/ 

Downloads/som107ap_c_lab.pdf) 

discusses CA for PPM laboratories. 

Therefore, we proposed clarifying, via 

modifications to this LD responsibilities 

section of the regulations, the CA 

requirement for PPM laboratories. We 

proposed that the LD evaluate the 

competency of all TP to ensure that the 

staff maintains their competency to 

perform test procedures and report test 

results promptly, accurately, and 

proficiently. This would include the 

following: 

• Direct observations of routine 

patient test performance, including 

patient preparation, if applicable, 

specimen handling, processing, and 

testing; 

• Monitoring the recording and 

reporting of test results; 

• Review of test results or 

worksheets; 

• Assessment of test performance 

through testing internal blind testing 

samples or external proficiency testing 

samples; and 

• Assessment of problem solving 

skills. 

Generally, these requirements mirror 

the CA provisions for moderate and 

high complexity testing at 

§§ 493.1413(b)(8) (technical consultant 

responsibilities) and 493.1451(b)(8) 

(technical supervisor responsibilities). 

We did not propose to include ‘‘Direct 

observation of performance of 

instrument maintenance and function 

checks’’ as the only equipment required 

for PPM testing is limited to bright-field 

and phase-contrast microscopy. 

Typically, TP do not perform these 

activities for PPM testing; rather, they 

are performed by third-party entities. 

In addition, we proposed at 

§ 493.1359(d) the same CA intervals as 

in §§ 493.1413(b)(8) and 493.1451(b)(8) 

apply to mid-level practitioners for 

consistency. That is, evaluating and 

documenting the performance of 

individuals responsible for PPM testing 

at least semiannually during the first 

year the individual tests patient 

specimens. Thereafter, evaluations must 

be performed at least annually. 

We received public comments on 

these proposals at § 493.1359. The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: A commenter suggested 

that TCs be allowed to perform PPM 

procedure CA. The commenter noted 

that TCs are not defined in the CLIA 

regulations but believes they are 

qualified to conduct CA for PPM 

procedures. The commenter also stated 

that allowing TCs to perform 

competency assessments would 

facilitate flexibility in meeting this 

requirement and reduce the burden on 

the LD. 

Response: Testing sites that hold a 

CLIA Certificate for Provider-performed 

Microscopy Procedures are subject to 

CLIA personnel regulations for the 

laboratory director (§§ 493.1355, 

493.1357, and 493.1359) and testing 

personnel only (§§ 493.1361, 493.1363, 

and 493.1365). CLIA does not have a 

personnel category for TC in PPM 

personnel requirements. The proposed 

CA provisions for LD of a PPM 

certificate mirror the CA provisions for 

moderate complexity testing at 

§ 493.1413(b)(8) (TC responsibilities). If 

a CLIA CoC or CoA laboratory performs 

PPM procedures, then that laboratory is 

subject to all CLIA regulations related to 

moderate complexity testing. In those 

laboratories with a CoC or CoA, a TC 

can perform CA for moderate 

complexity testing including PPM 

procedures under § 493.1413(b)(8). 

However, in a CLIA certificate for PPM, 

it will be the LD’s responsibility to 

perform CA. 

Comment: A commenter suggested 

reducing the frequency of conducting 

the CA of individuals responsible for 

PPM testing to every 2 years rather than 

annually. The commenter noted that 

PPM testing is often performed by 

physicians or licensed providers with 

advanced degrees and extensive training 

who are highly engaged in the clinical 

situations where they are conducting 

the testing. 

Response: PPM testing is moderate 

complexity per § 493.19(b)(2). The 

proposed CA intervals were kept the 

same as those for moderate and high 

complexity for consistency. 

Comment: A commenter supported 

requiring PPM LDs to undergo CAs at 

the same interval as moderate and high 

complexity laboratories. The commenter 

stated that since PPM laboratories are 

not inspected regularly, there currently 

needs to be a mechanism for State 

agencies to monitor CA activities to 

ensure compliance. The commenter 

suggested that CMS devise and 

implement reporting requirements and 

inspection methods for PPM 

laboratories. 

Response: CLIA Certificate for PPM 

Procedure laboratories must meet the 

applicable requirements for inspection 

under subpart Q of the CLIA 

regulations. We further note that 

reporting and inspection requirements 

are outside the scope of this rule. 

In the proposed rule, we used the 

following terms to refer to the providerperformed microscopy procedure 

certificate: Certificate for Provider 

Performed Microscopy Procedures 

(PPMP), Certificate of Provider 

Performed Microscopy (PPM), and 

Certificate for Provider Performed 

Microscopy (PPM). For internal 

consistency, we are updating these 

terms in this section and throughout 

this final rule to ‘‘Certificate for 

Provider-performed Microscopy (PPM) 

Procedures’’ when referring to the 

provider-performed microscopy 

procedures certificate. 

We also note that in this final rule, 

CMS is making technical changes to 

proposed section § 493.1359(d) to 

enhance consistency. 

After consideration of public 

comments, we are finalizing the changes 

to § 493.1359 as proposed, with 

modification for internal consistency at 

§ 493.1359(d). 

3. Laboratory Director Qualifications 

(§ 493.1405) 

At §§ 493.1405(b)(1)(ii), 

493.1411(b)(1)(ii), 493.1443(b)(1)(ii), 

and 493.1449, we proposed removing 

‘‘or possess qualifications that are 

equivalent to those required for such 

certification.’’ In making this proposal, 

we acknowledge that there are limited 

timeframes for an individual to sit for 

the boards, however, by allowing any 

such ‘‘eligible’’ individual to qualify 

under our regulations, we have found 

that some individuals may never sit for 

exams or may even fail the exams. Such 

individuals were not who we intended 

to be eligible under these provisions. 

Further, even if we were to ban such 

individuals by carving them out of those 

we considered to hold ‘‘qualifications 

that are equivalent to those required for 

certification,’’ it would be difficult to 

identify those individuals and remove 

them from their LD roles. In making this 

proposal, we acknowledged having 

historically accepted letters from 

individuals that have documented proof 

from the American Board of Pathology 

or American Board of Osteopathic 

Pathology that they are eligible to sit for 

the boards based on SOM guidance 

(https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/ 

Downloads/som107ap_c_lab.pdf, page 

351, D6078). In addition, we proposed 

eliminating the equivalency standard, as 


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we do not have a means to evaluate 

equivalency to other boards for 

equivalency to American Board of 

Pathology or American Board of 

Osteopathic Pathology as it would be up 

to the Board to make a determination of 

equivalency, and we do not believe in 

retrospect it would be appropriate to 

expect those entities to conduct such 

analyses. Furthermore, we had 

requested that CLIAC consider what 

‘‘possessing qualifications that are 

equivalent to board certification’’ 

should mean. CLIAC recommended that 

this verbiage be removed from relevant 

sections of subpart M because it was 

confusing, and we have no mechanism 

to determine when qualifications are 

‘‘equivalent to board certification.’’ We 

concur with the CLIAC 

recommendation. Further, we believe 

that individuals who historically may 

have qualified under this provision 

would still qualify through alternative 

routes, thus not disadvantaging 

individuals seeking to qualify as LDs. 

We further proposed that an individual 

who qualified under the predecessor 

regulations and is currently employed 

as a LD may continue to serve in that 

capacity so long as there is no break in 

service after the effective date of this 

final rule. For example, an individual 

who is serving as the LD of a CLIAcertified laboratory at the date of the 

publication of the final rule, and 

continues to serve as a LD of CLIAcertified laboratory that performs 

nonwaived testing, would continue to 

qualify. However, an individual who 

does not continue as LD of a CLIAcertified laboratory after the date of 

implementation of the final rule would 

need to requalify under the new 

provisions. 

At § 493.1405(b)(2)(ii)(A), we 

proposed changing the ‘‘or’’ to an ‘‘and’’ 

to include directing or supervising 

nonwaived laboratory testing in the 

provision. In addition, we proposed to 

remove ‘‘Beginning September 1, 1993’’ 

from § 493.1405(b)(2)(ii)(B) and 

continue to retain the provision for 20 

hours of CE credit hours for moderate 

complexity LDs who are seeking to 

qualify without certification by the 

American Board of Pathology and the 

American Board of Osteopathic 

Pathology. We believe by requiring the 

20 CE credit hours, the LDs would have 

a better understanding of their 

responsibilities in the overall 

management and direction of 

laboratories, which would result in 

improved overall compliance. 

Historically, LD citations are among the 

top 10 condition-level deficiencies cited 

by surveyors. We believe that this 

would also improve the ability of 

laboratories to report accurate and 

reliable test results, thus helping to 

protect the health and safety of the 

public. 

At §§ 493.1405(b)(2)(ii)(C) and 

493.1443(b)(2)(i), we proposed removing 

the residency provision for the 

following reasons. First, the residency 

requirement causes confusion with 

board certification for doctoral degrees 

(for example, American Board of 

Internal Medicine). It is also challenging 

for these individuals to qualify under 

this provision as the medical 

residencies generally do not include the 

type of laboratory training or require the 

1 year of laboratory training that we 

would expect to see related to laboratory 

administration and operation for which 

the LD is responsible. We would expect 

the residency program to provide an 

individual with essential information 

regarding the principles and theories of 

laboratory practice, including quality 

control and quality assessment; 

proficiency testing; the phases of the 

total process (that is, pre-analytic, 

analytic, and post-analytic), as well as 

general laboratory systems; facility 

administration; and development and 

implementation of personnel policy and 

procedure manuals. This training 

should also include hands-on laboratory 

testing. However, a typical residency 

does not include a year of laboratory 

training (defined in interpretive 

guidelines as 2,080 hours of laboratory 

training) nor does it include essential 

information on the principles and 

theories of laboratory practice. We have 

observed, and AOs have noted to us, 

that very few individuals qualify 

through the medical residency route. 

The onus for providing the 

documentation related to clinical 

laboratory experience during residency 

is on the applicants (that is, the 

applicants must document their clinical 

laboratory experience during residency). 

CLIAC recommended that we clarify 

the residency requirements by 

emphasizing the requisite laboratory 

training must be ‘‘clinical laboratory 

training,’’ meaning ‘‘have at least one 

year of clinical laboratory training 

during medical residency or 

fellowship.’’ However, we believe that 1 

year of laboratory training is vague. We 

also believe that after removing the 

residency requirement, there would be 

several alternative routes for individuals 

to qualify as LDs. Individuals seeking to 

qualify as a moderate complexity LD 

may still qualify under § 493.1405(b)(3) 

through (5) without a medical 

residency. We would continue to accept 

residency experience as counting 

toward the requirement of 2 years of 

laboratory experience directing or 

supervising high complexity testing for 

doctors of medicine, doctors of 

osteopathy, or doctors of podiatry. We 

would also accept experience directing 

or supervising high complexity testing 

from a medical fellowship program 

toward the requirements outlined in the 

regulations. Generally, a fellowship 

program follows a residency program 

and is for those individuals who choose 

to pursue additional training in their 

specialty. Section 493.1443(b)(2)(ii) is 

the current requirement that allows 

individuals with at least 2 years of 

experience directing or supervising high 

complexity testing to qualify under 

paragraph (b)(2). 

At § 493.1405(b)(3), we proposed 

revising paragraph (b)(3)(ii) to include 

an educational option that includes a 

qualification algorithm for an individual 

that does not have an earned doctoral 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology (see section I.D.1.a of the 

proposed rule). We also proposed 

adding paragraph (b)(3)(iii) to include 

the addition of 20 CE credit hours for 

doctoral degrees, as well as the current 

paragraphs (b)(3)(i) through (ii). This 

would include the requirement to be 

certified by an applicable board and 

continue to be certified and have at least 

1 year of experience directing or 

supervising nonwaived testing. (As 

discussed later in this section of the 

final rule, these provisions in the 

proposed rule at § 493.1405(b)(3) are 

being reformatted and finalized at the 

revised (b)(3)(i) through (ii).) 

The current CLIA regulations at 

§§ 493.1405, 493.1411, 493.1423, 

493.1441, 493.1449, 494.1461, and 

493.1489 indicate acceptable degrees for 

personnel as those in a chemical, 

physical, biological science, or clinical 

laboratory science or medical 

technology. Degree names and types 

have changed since the CLIA 

regulations were first published in 1992. 

As a result, in some cases, there are 

degrees for which the area of study may 

not be clear based on the name of the 

degree given. This makes it challenging 

for CMS, State agencies, Exempt States 

(ES), and AOs to determine what types 

of degrees are considered acceptable 

degrees in order to qualify CLIA 

personnel. At the time the CLIA 

regulations were published, individuals 

typically received a degree in the areas 

of biology, chemistry, medical 

technology, or clinical laboratory 

science. Today, we often must perform 

an evaluation of transcripts to determine 

if the individuals meet CLIA personnel 

requirements. 


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We believe it is important that 

individuals lacking a traditional degree 

in chemical, biological, or clinical 

laboratory science or medical 

technology should be considered if they 

have completed the coursework that is 

equivalent to the aforementioned 

traditional degrees and acquired 

documentation of the equivalent 

educational coursework. In addition to 

the educational requirements discussed 

in this section, CLIA also has experience 

and training requirements (see our 

proposed updates to §§ 493.1405, 

493.1411, and 493.1423), but they will 

not be addressed in this educational 

discussion. 

We believe degrees should be in a 

science that deals in the kind of clinical 

laboratory testing, that is related to 

testing of human specimens as the 

definition of a ‘‘laboratory,’’ which is 

defined in terms of the examination of 

materials from the human body for the 

purposes of providing information for 

the diagnosis, prevention, or treatment 

of any disease or impairment of, or the 

assessment of the health of human 

beings (see § 493.2). In some cases, it is 

clear that a degree would meet these 

standards. For example, degrees in 

microbiology, genetics, molecular 

biology, biochemistry, and organic 

chemistry would be considered 

appropriate degrees. In other instances, 

it is not apparent whether the degree 

would meet such requirements. 

Environmental sciences, biotechnology, 

and marine biology are examples of 

degrees that would not appear in 

keeping with the scope of the CLIA 

program. At face value, we do not 

believe these types of degrees should 

qualify an individual under the 

requirements in subpart M because they 

are not related to clinical laboratory 

testing. Environmental science degrees 

may cover such areas as ecosystem 

management, the impact of 

industrialization on the environment, 

and natural resource management. 

Biotechnology degrees focus on 

developing technologies and products 

related to medical, environmental, and 

industrial areas. Marine biology focuses 

on studying marine organisms, their 

behaviors, and interactions with the 

environment. We would not consider 

these to be appropriate degrees under 

the CLIA program because these degrees 

do not generally appear to be focused on 

clinical laboratory testing or focused on 

the testing of human specimens, which 

is the scope of the CLIA regulations. 

However, in the proposed rule, we 

proposed an option for an educational 

algorithm based on semester hours (SH) 

as an alternative qualification 

mechanism. We stated in the proposed 

rule that if finalized, individuals with 

degrees that are not clearly biological or 

chemical in nature may be evaluated 

using this algorithm and may qualify for 

CLIA personnel positions in subpart M. 

In developing the proposed algorithm, 

we explored the required courses for 

bachelor’s, master’s, and doctoral 

degrees in the major studies of biology, 

chemistry, and medical technology. For 

purposes of this discussion, only 

degrees in biology and chemistry will be 

addressed, as degrees in medical 

technology and clinical laboratory 

science do not need to be evaluated for 

equivalency. Multiple sections of the 

CLIA regulations specify that 

educational degrees in ‘‘chemical, 

physical or biological science or 

medical laboratory technology from an 

accredited institution’’ constitute 

appropriate education to qualify for 

laboratory roles in the noted complexity 

and laboratory specialty areas. In all 

situations, the educational requirement 

is based on the laboratory individual 

having a sufficient educational 

background (coursework) to be qualified 

to gain the subsequent training and 

experience to competently perform their 

roles. 

Three levels (small, medium, and 

large) of both public and private 

accredited universities and colleges 

were reviewed. For purposes of this 

research, small institutions were 

defined as less than 5,000 students, 

medium as 5,000 to 15,000 students, 

and large as greater than 15,000 

students. Seven colleges and 

universities were evaluated for all three 

defined types. Table 9 describes the 

number of SH required across all three 

sizes of colleges and universities for 

both a bachelor’s in Biology and a 

bachelor’s in Chemistry. 

In general, accredited colleges and 

universities require general biology, 

molecular biology or genetics, general 

chemistry, organic chemistry, and 

biochemistry. We proposed a specific 

coursework algorithm to qualify 

candidates, in lieu of a qualifying 

degree, for all testing levels. At present, 

only § 493.1489(b)(2)(ii) specifies 

specific coursework required. This is for 

an associate degree individual to 

perform high complexity testing. 

Specifying coursework requirements 

will allow CMS, State agencies (SA), 

accreditation organizations (AO), and 

exempt States (ES) to consistently 

evaluate educational qualifications. 

For both the doctoral degree and 

master’s degree curricula, there were no 

consistent coursework, thesis or 

research requirements for Biology and 

Chemistry majors of study. For example, 

evaluation of the master’s degree 

requirements revealed three tracks that 

included: 

• Coursework; 

• Coursework and thesis; and 

• Coursework, thesis, and research. 

For doctoral degrees, we proposed the 

following educational algorithm for 

those individuals who have a doctoral 

degree that is not clearly in a chemical 

or biological science. We stated that we 

would expect those individuals to: 

• Meet master’s degree equivalency; 

and 

• At least 16 SH of additional 

doctoral-level coursework in biology, 


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TABLE 9: Average Required Semester Hours (SH)* for Bachelor's Degrees in Biology and 

Chemistry 

Semester Hours (SH) Bachelor's Biolo2Y Bachelor's Chemistry 

Biology SH 20-49 ;:::8** 

Chemistrv SH 8-20 25-56 

Other (Includes biology/chemistry) 7-28 11-42 

* Quarter hours may be converted to semester hours by multiplying the semester hours by 1.5. For example, 3 

semester hours is equivalent to 4.5 quarter hours. 

**The majority of colleges and universities did not break out the biology SH, but instead grouped 

them in "Other". 
90006 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

chemistry, medical technology, or 

clinical laboratory science; and 

• A thesis or research project in 

biology, chemistry, medical technology, 

or clinical laboratory science related to 

laboratory testing for the diagnosis, 

prevention, or treatment of any disease 

or impairment of or the assessment of 

the health of human beings. 

CLIAC recommended that other 

degrees (such as those in the 

humanities, physical sciences, and 

others) may not have the requisite 

science coursework, and candidates for 

positions should be considered based on 

a minimum number of hours of courses 

with laboratory components with 

relevance to clinical laboratory testing 

(which could also come from post 

degree curricular work). We concur with 

CLIAC’s recommendation that relevant 

science and laboratory coursework 

should be considered when evaluating 

an individual’s education qualifications. 

The educational algorithm may allow 

individuals without a traditional 

chemical or biological degree to meet 

the CLIA personnel education 

requirements based on their 

coursework. Individuals who may have 

the appropriate coursework would not 

be disadvantaged by having a degree 

that is not considered chemical or 

biological in nature. Please note that the 

requirements for the applicable 

laboratory training or experience, or 

both, found in subpart M (and discussed 

previously), are required in addition to 

the educational requirement. 

At § 493.1405(b)(4), we proposed 

redesignating current paragraphs 

(b)(4)(ii) and (iii) as paragraphs (b)(4)(iv) 

and (v), respectively. We proposed new 

paragraphs (b)(4)(ii) and (iii) as 

additional educational options that 

include a qualification algorithm for an 

individual that does not have a master’s 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology (see section III.B.3. of the 

proposed rule). We proposed adding a 

new requirement at paragraph (b)(4)(vi) 

to include the addition of 20 CE credit 

hours. (As discussed later in this section 

of the final rule, these provisions in the 

proposed rule at § 493.1405(b)(4) are 

being reformatted and finalized at the 

revised (b)(4)(i) through (iv)). 

As a result of the above discussion, 

we proposed that individuals meet 

either of the following two options for 

use as educational algorithms: 

• Option 1 

++ Meet bachelor’s degree 

equivalency; and 

++ At least 16 SH of additional 

graduate level coursework in biology, 

chemistry, medical technology, or 

clinical laboratory science; or 

• Option 2 

++ Meet bachelor’s degree 

equivalency; and 

++ At least 16 SH, which may 

include a combination of graduate level 

coursework in biology, chemistry, 

medical technology, or clinical 

laboratory science and a thesis or 

research project related to laboratory 

testing for the diagnosis, prevention, or 

treatment of any disease or impairment 

of, or the assessment of the health of, 

human beings. 

At § 493.1405(b)(5), we proposed 

redesignating current paragraphs 

(b)(5)(ii) and (iii) to paragraphs (b)(5)(iii) 

and (iv), respectively. In addition, we 

proposed a new paragraph (b)(5)(ii) with 

an educational option that includes a 

qualification algorithm for an individual 

that does not have a bachelor’s degree 

in a chemical, biological, or clinical 

laboratory science or medical 

technology (see section I.D.1.c. of the 

proposed rule). We also proposed 

adding a new requirement at paragraph 

(b)(5)(v) to include the addition of 20 CE 

credit hours. (As discussed later in this 

section of the final rule, these 

provisions in the proposed rule at 

§ 493.1405(b)(5) are being reformatted 

and finalized at the revised (b)(5)(i) 

through (iv)). 

In general, an associate degree 

requires the completion of 60 SH, and 

a bachelor’s degree requires the 

completion of 120 SH. In the case of 

bachelor’s degrees, for this reason, we 

proposed that the equivalent 

educational requirements for associate 

degrees at the existing 

§ 493.1489(b)(2)(ii) should be doubled. 

That is, an individual must have at least 

120 SH, or equivalent, from an 

accredited institution that, at a 

minimum, include either 48 SH of 

medical laboratory technology or 

clinical laboratory science courses; or 48 

SH of science courses that include: 12 

SH of chemistry, which must include 

general chemistry and biochemistry or 

organic chemistry; 12 SH of biology, 

which must include general biology and 

molecular biology, cell biology or 

genetics; and 24 SH of chemistry, 

biology, or medical laboratory 

technology or clinical laboratory science 

in any combination. (Note: We did not 

propose to amend the education SH 

requirements at the existing 

§ 493.1489(b)(2)(ii) in the proposed rule, 

as there is no need to amend. However, 

in the proposed and now final rule, the 

existing § 493.1489(b)(2)(ii) is 

redesignated and reformatted as 

§ 493.1489(b)(3)(ii)). 

In addition to the degrees discussed 

previously in this rule, we proposed a 

new framework for evaluating nontraditional degrees, a part of the 

educational algorithm described 

previously. One example of a nontraditional degree may be a Regents 

Bachelor of Arts (RBA), which is a 

baccalaureate degree program designed 

for adult students. The basic principle 

of an RBA is that credit is awarded for 

what students know, regardless of how 

that knowledge was obtained. In other 

words, students may earn college 

equivalent credit for work and life 

experiences that can be equated to 

college courses. It is designed to provide 

students with a comprehensive general 

education. Many times, no specific 

courses are required for graduation, 

allowing students to design their own 

programs of study. This degree is 

usually awarded by a Board of Regents. 

It is a general education degree without 

the designation of a major. Many of 

these individuals have an associate 

degree in medical laboratory technology 

(MLT), but not an appropriate bachelor’s 

degree that would make them eligible to 

qualify under the provisions in CLIA 

personnel requirements that require a 

minimum of a bachelor’s degree in 

specified scientific fields. This becomes 

problematic because the RBA does not 

designate a major. Generally, in these 

cases, we have seen that these 

individuals have an associate degree in 

MLT and have many years of clinical 

laboratory experience. Currently, these 

individuals cannot meet CLIA personnel 

qualifications in subpart M that require 

a minimum of a bachelor’s degree. We 

believe that their education and 

experience should qualify them to be 

TCs as long as their associate degree is 

in medical laboratory technology or 

laboratory science. Public feedback from 

the 2018 RFI supported that a nontraditional degree should be considered 

as a means to meet CLIA requirements 

for the TC and TP for moderate 

complexity testing, provided a 

minimum number of SH were obtained 

in chemistry, biology, and laboratory 

sciences. We believe a non-traditional 

degree can be a means to qualify as TC 

and TP, provided an adequate number 

of biology, chemistry or medical 

laboratory, or clinical laboratory science 

courses is part of the curriculum in 

addition to meeting the training or 

experience requirements. However, we 

do not believe a nontraditional degree 

can be a means to qualify as a laboratory 

director. 

At § 493.1405(b)(6) through (7), we 

proposed removing the ‘‘grandfather’’ 

provisions as these requirements had to 


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Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90007 

have been met by February 28, 1992. 

Individuals can no longer qualify under 

these provisions. A grandfather is a 

provision in which a previous rule 

would continue to apply to individuals 

already qualified and employed in the 

given personnel capacity upon 

implementing a new rule. The new rule 

will apply to all individuals seeking to 

qualify after the implementation of said 

rule. We proposed to revise paragraph 

(b)(6) with a new grandfather provision 

for all individuals who qualified under 

this provision, as well as § 493.1406, 

prior to the date of the final rule. We 

stated in the proposed rule that we 

intend to allow individuals already 

qualified and employed in the given 

personnel capacity as of the date of the 

final rule to continue to be qualified 

under the new provisions (that is, 

grandfathered). However, we stated that 

we intend to require all individuals 

becoming employed by a laboratory or 

changing assignments within a 

laboratory after the final rule’s effective 

date to qualify under the new 

provisions. This includes those 

individuals who may have been 

previously employed in a given position 

prior to the effective date but took a 

break or a leave of absence and came 

back after the date of the final rule. 

We received public comments on 

these proposed provisions at § 493.1405. 

The following is a summary of the 

public comments we received and our 

responses. 

Comment: A commenter suggested a 

formal recognition of board certification 

in MT, CLS, MLS, and other 

subspecialties instead of qualifications 

based on coursework. The commenter 

added that accreditation organizations 

need to recognize board certification 

because they are not required in the 

CLIA regulations. According to the 

commenter, those with ASCP and other 

certifications are higher qualified 

laboratory scientists who meet the CLIA 

minimum. The commenter further 

stated that it is often easier to obtain 

certification verification than to prove 

degree coursework, especially from 

schools or programs that no longer exist. 

Response: We believe this type of 

documentation is not sufficient 

evidence of meeting the personnel 

qualifications. We have found that the 

certifying boards may certify 

individuals as MT, CLS, and MLS with 

a variety of degrees if they meet an 

educational algorithm. Their 

coursework may not meet the minimum 

CLIA personnel requirements, but there 

may be enough science classes to sit for 

the examination and be certified as an 

MT, CLS, or MLS. In addition, not all 

certifying boards have the same 

requirements for certification. We will 

continue requiring detailed information, 

such as degrees, transcripts, or Primary 

Source Verification (PSV) documents, to 

verify educational credentials per the 

policy memorandum, S&C: 16–18–CLIA 

(https://www.cms.gov/Medicare/ 

Provider-Enrollment-and-Certification/ 

SurveyCertificationGenInfo/Downloads/ 

Survey-and-Cert-Letter-16-18.pdf). 

Comment: Several commenters noted 

the 2022 decision by AMT, ASCP, and 

ASCLS to change the MT certification 

designation to MLS. The commenters 

suggested that medical laboratory 

science should be used in addition to 

clinical laboratory science throughout 

the CLIA personnel qualifications. 

Response: We agree with the 

commenters that medical laboratory 

science should be included in the 

revised personnel qualifications. We are 

incorporating the change suggested by 

the commenters where applicable in 

revised § 493.1405 and other applicable 

sections of subpart M. 

Comment: Many commenters agreed 

with the removal of ‘‘physical science’’ 

as a degree. A commenter stated that 

defining specific courses of study which 

must be completed to qualify as a LD 

(that is, biochemistry or organic 

chemistry; molecular biology, cell 

biology, or genetics) unfairly 

discriminates against degree programs 

that impart the necessary knowledge to 

perform the duties of LD but do not 

include these specific courses. The 

commenter added that foreign and 

alternative degrees might also prepare a 

person to perform the LD duties better 

than degree programs that have those 

specific courses. 

Response: We believe it is important 

that individuals lacking a traditional 

degree in chemical, biological, clinical, 

or medical laboratory science or medical 

technology should be considered if they 

have completed the coursework 

equivalent to the aforementioned 

traditional degrees and acquired 

documentation of the equivalent 

educational coursework. In response to 

the 2018 RFI (83 FR 1005 through 1006, 

1008), commenters recommended that 

we evaluate coursework taken using an 

SH educational algorithm to qualify 

individuals for CLIA personnel 

positions. CLIAC also stated that 

degrees (such as those in the 

humanities, physical sciences, and 

others) might require the requisite 

science coursework. The courses 

indicated in the proposed algorithm 

meet the CLIAC recommendation for 

courses with laboratory components 

relevant to clinical laboratory testing. 

Comment: A commenter opposed 

lowering of educational standards for 

LD and disagreed with the proposal to 

add a qualification pathway for 

moderate and high-complexity LD that 

includes an educational algorithm for an 

individual that does not have an earned 

doctoral degree in a chemical, 

biological, or clinical laboratory science 

or medical technology. The commenter 

suggested that a doctorate-level or 

medical doctor degree should be the 

minimum educational qualification for 

LD, given the importance of the role of 

overseeing the overall management and 

operations of the clinical laboratory. 

Response: We agree that the doctoral 

degree algorithm requires, at a 

minimum, a doctoral degree and 

therefore are revising proposed 

§ 493.1405(b)(3)(ii)(A) (finalized at 

§ 493.1405(b)(3)(i)(B)) to specify that the 

individual must have an earned doctoral 

degree for purposes of the doctoral 

degree algorithm. However, we do not 

agree that LDs of a laboratory 

performing moderate-complexity testing 

require a doctoral degree. Since 1992 

the CLIA LD qualifications for 

laboratories performing moderate 

complexity testing (§ 493.1405) have 

provided pathways for individuals with 

a master’s or bachelor’s degree to qualify 

as moderate complexity LD. The 

proposed moderate complexity LD 

qualifications for master’s and 

bachelor’s degrees courses indicated in 

the proposed algorithm meet the CLIAC 

recommendation for courses with 

laboratory components relevant to 

clinical laboratory testing. 

In this final rule, consistent with our 

proposed and final policy, we are also 

reformatting proposed § 493.1405(b)(3) 

to clarify that both individuals 

qualifying with a traditional doctoral 

degree and those qualifying under the 

new educational pathway, must have 

the specified 20 CE credit hours, 

certification, and experience. As we 

explained in the July 2022 proposed 

rule (87 FR 44914), these requirements 

apply to individuals qualifying with 

doctoral degrees. We are also 

reformatting proposed § 493.1405(b)(4) 

and (5) to clarify that individuals 

qualifying with a traditional master’s or 

bachelor’s degree and those qualifying 

under the new educational pathway 

must all have the required laboratory 

training or experience and CE credits, as 

we discussed in the July 2022 proposed 

rule (87 FR 44915–44916). 

Also at § 493.1405(b)(4)(i)(C)(2) of this 

final rule we are revising to clarify that 

under this educational pathway, 16 

semester hours in a combination of 

graduate level coursework in specified 

subjects and a thesis or research project 

related to CLIA laboratory testing is 

required. At the final regulations at both 


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21https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/ 

CLIAtopten.pdf. 

§ 493.1405(b)(3)(i)(B)(2) and 

(b)(4)(i)(C)(2), we are clarifying that for 

those who qualify with a thesis or 

research project, that thesis or research 

project must be approved, meaning the 

individuals must have received credit 

for it as reflected on their transcript. 

CMS’s policy is to verify educational 

qualifications by reviewing transcripts, 

as described in its Survey and 

Certification Memorandum 16–18– 

CLIA, Personnel Policies for Individuals 

Directing or Performing Non-waived 

Tests at 2–4 (April 1, 2016), available at 

https://www.cms.gov/medicare/ 

provider-enrollment-and-certification/ 

surveycertificationgeninfo/policy-andmemos-to-states-and-regions-items/ 

survey-and-cert-letter-16-18. 

We are also making technical changes 

in this section of the regulatory text in 

this final rule to enhance consistency. 

After consideration of public 

comments, we are finalizing the 

proposed provisions at § 493.1405, with 

the following modifications: 

• To specify at § 493.1405(b)(3)(i)(B) 

that for purposes of the doctoral degree 

algorithm, an individual must hold an 

earned doctoral degree, 

• To reformat the regulations at 

§ 493.1405(b)(3) through (5). 

• To revise § 493.1405(b)(3)(i)(B)(2) 

and (b)(4)(i)(C)(2) as described 

previously. 

• To include medical laboratory 

science in § 493.1405 where applicable. 

4. Laboratory Director Qualifications on 

or Before February 28, 1992 (§ 493.1406) 

At § 493.1406, we proposed removing 

the grandfather provision for these 

requirements as they had to have been 

met by February 28, 1992. Individuals 

can no longer qualify under these 

provisions. We stated in the proposed 

rule that we plan to grandfather all 

individuals qualified under this 

provision prior to the date of the final 

rule under § 493.1405(b)(6). All 

individuals qualifying after the date of 

the final rule will be required to qualify 

under the new provisions. 

We received no public comments on 

this provision and are finalizing the 

proposed removal of § 493.1406. 

5. Laboratory Director Responsibilities 

(§ 493.1407) 

At §§ 493.1407(c) and 493.1445(c), we 

proposed revising the requirements so 

that the LD must be on-site at the 

laboratory at least once every 6 months, 

with at least a 4-month interval between 

the two on-site visits. However, LDs 

may elect to be on-site more frequently. 

The laboratory must provide 

documentation of these visits, including 

evidence of performing activities that 

are part of the LD responsibilities. We 

concur with CLIAC’s recommendation 

that LDs should make at least two 

(reasonably spaced) on-site visits to 

each laboratory they direct per year. We 

stated that we would expect the on-site 

visits to be once every 6 months with an 

interval of at least 4 months between the 

two on-site visits. We will continue to 

require that the LD be accessible to the 

laboratory to provide telephone or 

electronic consultation as needed. Based 

on a review of information provided by 

State agencies, AOs, and ESs, onsite LD 

visits are required as follows: 

• 19 percent (n=10 of 54), meaning 9 

non-exempt States plus 1 territory 

require on-site visits out of 54 States 

and territories; 

• 43 percent (n=3 of 7) AOs; and 

• 50 percent (n=1 of 2) ES. 

CLIA statistics show that LD citations 

are consistently among the top 10 

condition level- deficiencies cited by 

surveyors.21 Feedback from the States, 

AOs, and ES indicated that the number 

of deficiencies cited at the time of the 

survey was less when the LD was onsite full-time or made regular on-site 

visits. Based on anecdotal information 

from the State agencies, ES, and AOs, 

the laboratories that did not have a LD 

who made regular visits to the 

laboratory tended to have an increased 

number of citations related to overall 

noncompliance with laboratory 

requirements. Some States currently 

require on-site LDs to visit their 

laboratory at prescribed intervals, while 

others do not (see Table 10 for a 

complete list of States and territories). 

Feedback from States and AOs that did 

not have such a requirement for on-site 

visits, generally supported the addition 

of a requirement for on-site visits. 

Further, on-site visits are meant to 

supplement regular interactions 

between off-site directors and the lab 

(for example, by telephone or other 

telepresence). We concur with CLIAC’s 

recommendations that clear 

documentation of LD on-site visits 

should demonstrate the laboratory is in 

continuous compliance with current 

laws and regulations, including but not 

limited to the assessment of the physical 

environment for safe laboratory testing. 

The on-site LD visits cannot be 

delegated. We believe adding the on-site 

requirement supports increased 

compliance for laboratories. 

BILLING CODE 4120–01–P 


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BILLING CODE 4120–01–C 

We received public comments on 

these proposals at § 493.1407. The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: Several commenters 

requested clarification regarding the 

definition of a laboratory site visit. One 

commenter noted that there could be 

several physician offices, outpatient 

clinics, hospital rooms, operating 

rooms, and other settings performing 

moderate complexity testing under a 

single CLIA certificate. The commenter 

questioned if the LD on-site visit 


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TABLE 10: State and Territorial Requirements for On-site Laboratory Directors Every 6 

Months 

Requirement for On-site Laboratory Directors Do not Require On-site Laboratory Directors 

Everv 6 Months Once Everv 6 Months 

Georgia Alabama 

Hawaii Alaska 

Maine American Samoa (territory) 

Maryland Arkansas 

Nevada Arizona 

New York* California 

Oklahoma Colorado 

Pennsylvania Connecticut 

Rhode Island Delaware 

Tennessee District of Columbia 

Puerto Rico (territory) Florida 

Guam (territory) 

Idaho 

Illinois 

Indiana 

Iowa 

Kansas 

Kentucky 

Louisiana 

Massachusetts 

Michigan 

Minnesota 

Mississippi 

Missouri 

Montana 

North Carolina 

North Dakota 

Nebraska 

New Hampshire 

New Jersey 

New Mexico 

Ohio 

Oregon 

Saipan (territory) 

South Carolina 

South Dakota 

Texas 

Utah 

Vermont 

Virginia 

Virgin Islands (territory) 

Washington** 

West Virginia 

Wisconsin 

Wyoming 

N=9 States+ 1 US territory, 1 ES* N=40 States,4 US territories,+ District of Columbia, 

1 ES** 
90010 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

pertains to all locations under a single 

CLIA certificate or just a single site. 

Another commenter was concerned that 

the proposed language regarding LD site 

visit requirements does not exempt 

CLIA home office sites. The commenter 

stated that existing and proposed CMS 

regulations still consider CLIA home 

office sites as ‘laboratories,’ which is 

inconsistent with common sense 

definitions of the non-laboratory 

activities occurring at these locations 

and suggested that CMS update and 

streamline regulations to accurately 

reflect the minimal scope of activities 

occurring at these home office locations. 

Another commenter noted that no data 

nor statistics were provided to support 

the perception that clinical laboratories 

with more regular on-site LD presence 

have fewer quality issues or lower 

number of deficiencies than those with 

less on-site LD presence. The 

commenter requested flexibility 

concerning the timeframes for the 

proposed visits by the CLIA LD to each 

of the clinical laboratories and 

suggested one on-site visit for 

laboratories with a limited scope of 

specialties (three or less) and a low 

volume of tests (2,000–10,000 per year), 

flexibility with the 4-month separation 

between 6-month visits, and allowance 

for virtual visits as an option also to 

meet the proposed requirement, which 

it stated would be economically and 

logistically beneficial. 

Response: CLIAC recommended that 

LDs make at least two (reasonably 

spaced) on-site visits to each laboratory 

they direct annually. As noted in the 

proposed rule, some States require onsite LDs to visit their laboratories at 

prescribed intervals. In contrast, others 

do not, and feedback from States and 

AOs that did not have such a 

requirement for on-site visits generally 

supported the addition of a requirement 

for on-site visits. The on-site visit 

requirement pertains to only one 

location site visit per CLIA certificate. 

However, LDs may elect to be on-site 

more frequently. If a home office is used 

under the oversight of a primary 

laboratory CLIA certificate, then that 

primary site’s LD will determine if the 

home office should be included in the 

on-site inspection. If a home office 

holds its own CoC or CoA, the LD must 

inspect those sites at the frequency 

specified in this final rule. 

Comment: A commenter requested 

clarification regarding the LD 

requirement to document the visits and 

include evidence of performing 

activities. 

Response: As currently required by 

CLIA under § 493.1407(e), the LD must 

ensure that the laboratory is in 

continuous compliance with current 

laws and regulations. The 

documentation required in the final 

§ 493.1407(c) must be sufficient for the 

LD to demonstrate compliance with this 

provision. The LD determines the type 

or process of documentation needed as 

evidence of performing visits. 

Documentation may include, but is not 

limited to, sign in/sign out logs, meeting 

minutes/summary, notes of 

observations, and travel vouchers. 

After consideration of public 

comments, we are finalizing the 

proposed provisions at § 493.1407(c) 

without modifications. 

6. Technical Consultant Qualifications 

(§ 493.1411) 

As discussed in section III.B.3. of the 

proposed rule, we proposed to amend 

§ 493.1411(b)(1)(ii) by removing ‘‘or 

possess qualifications that are 

equivalent to those required for such 

certification.’’ 

As discussed in section III.B.17. of the 

proposed rule, we proposed to amend 

§ 493.1411(b)(3)(i) by removing an 

earned doctoral, master’s, or bachelor’s 

degree in ‘‘physical science’’ as a means 

to qualify. We further proposed to 

redesignate current paragraph (b)(3)(ii) 

as paragraph (b)(3)(iii). Then, we 

proposed to revise paragraph (b)(3)(i) by 

changing the ‘‘and’’ to an ‘‘or’’ and to 

add a requirement at new paragraph 

(b)(3)(ii) to meet either 

§ 493.1405(b)(3)(ii) or (b)(4)(ii) or (iii) to 

allow individuals who do not have a 

chemical, biological, or clinical 

laboratory science or medical 

technology degree to be eligible to 

qualify as a TC using the educational 

algorithm. (As discussed later in this 

section of the final rule, these 

provisions in the proposed rule at 

§ 493.1411(b)(3) are being reformatted 

and finalized at revised (b)(3)(i) and 

(ii).) 

As discussed in section III.B. 17 of the 

proposed rule, we proposed to revise 

§ 493.1411(b)(4)(i) by removing a 

doctoral, master’s, or bachelor’s degree 

in ‘‘physical science’’ as a means to 

qualify, and adding an earned doctoral, 

master’s, or bachelor’s degree in 

‘‘clinical laboratory science’’ as a means 

to qualify. At § 493.1411(b)(4), we 

proposed changing the ‘‘and’’ to an ‘‘or’’ 

in paragraph (b)(4)(i). We also proposed 

to redesignate current paragraph 

(b)(4)(ii) as paragraph (b)(4)(iii) and to 

add a new paragraph (b)(4)(ii) to state 

that the individual must meet the 

criteria in § 493.1405(b)(5)(ii) (finalized 

in this final rule at 

§ 493.1405(b)(5)(i)(B)) to allow 

individuals who do not have a 

chemical, biological, or clinical 

laboratory science or medical 

technology degree to be eligible to 

qualify as a TC using the educational 

algorithm. We stated we would also 

redesignate the current 

§ 493.1405(b)(5)(ii) as 

§ 493.1405(b)(5)(iii) and added an ‘‘or’’ 

following proposed § 493.1405(b)(5)(i). 

(As discussed later in this section of the 

final rule, these provisions in the 

proposed rule at § 493.1411(b)(4) are 

being reformatted and finalized at the 

revised (b)(4)(i) and (ii).) 

At § 493.1411(b), we proposed adding 

a requirement at paragraph (b)(5) to 

allow individuals with an associate 

degree in medical laboratory technology 

or clinical laboratory science and at 

least 4 years of laboratory training or 

experience, or both, in nonwaived 

testing and the designated specialty or 

subspecialty areas of service for which 

the TC is responsible for qualifying as 

TCs. As discussed in section I.B. of the 

proposed rule, CLIAC recommended 

that we modify CLIA requirements to 

add the option for individuals with an 

associate degree to qualify as TCs. We 

concur with the CLIAC 

recommendation. In general, this will 

allow individuals who may have an 

applicable associate degree in addition 

to required training or experience, or 

both, to qualify as TCs. We recognize 

that the current personnel qualifications 

for general supervisors (GS) for high 

complexity testing may be less stringent 

than those of TCs for moderate 

complexity testing. The current CLIA 

regulations allow an individual with an 

associate degree (§ 493.1461) to perform 

CA on high complexity TP (see 

§§ 493.1461(c)(2), 493.1489(b)(2)(i)). The 

regulations under moderate complexity 

state that the TC is responsible for CA 

and does not allow delegation of this 

responsibility to any individual. The 

high complexity regulations allow the 

LD or TS to delegate the CA to the GS. 

However, the same individual cannot 

perform CA on TP for moderate 

complexity testing unless they can 

qualify as a TC. Therefore, if a 

laboratory performs both moderate and 

high complexity testing, a GS can only 

perform CA on moderate complexity TP 

if they can meet the regulatory 

requirements of a TC. The proposed 

change would allow individuals with 

applicable associate degrees to assess 

competency in laboratories that perform 

both moderate and high complexity 

testing and bring parity to who performs 

CA for all nonwaived laboratories while 

maintaining the laboratory’s ability to 

produce accurate and reliable testing. 

At § 493.1411(b), we proposed adding 

a requirement at paragraph (b)(6) to 

allow individuals who are qualified 


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Continued 

under § 493.1411(b)(1), (2), (3), or (4) or 

have earned a bachelor’s degree in 

respiratory therapy or cardiovascular 

technology from an accredited 

institution and have at least 2 years of 

laboratory training or experience, or 

both, in blood gas analysis to qualify as 

TC for blood gas testing only. Most 

blood gas testing was categorized as 

high complexity when the original 

regulations were finalized in the 

February 1992 final rule with comment 

period. Due to improved technology, 

most routine blood gas testing is now 

categorized as moderate complexity. We 

proposed this change because we 

believe that it would provide adequate 

oversight of moderate complexity blood 

gas testing. Adding this provision 

specific to TCs in the area of blood gas 

testing would allow individuals to 

qualify as a TC in this specific area of 

expertise. Please note that we will still 

not consider a degree in respiratory 

therapy (RT) or cardiovascular 

technology to be equivalent to a 

biological or chemical science degree. 

However, an individual with a degree in 

either respiratory or cardiovascular 

therapy would be able to oversee the 

testing and CA of only those personnel 

who perform blood gas testing. 

At § 493.1411(b)(7), we proposed 

adding a grandfather provision to 

include those already qualified prior to 

the date of the final rule, including 

nurses. 

We received public comments on 

these proposals at § 493.1411. The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: Several commenters 

supported the proposed TC qualification 

route for an associate degree in medical 

laboratory technology or clinical 

laboratory science and at least 4 years of 

laboratory training or experience, or 

both, in nonwaived testing and the 

designated specialty or subspecialty 

areas of service for which the TC is 

responsible for qualifying as TCs. 

Response: We appreciate the 

commenters’ support and are finalizing 

these proposed changes with 

modification, to include medical 

laboratory science in addition to 

medical laboratory technology and 

clinical laboratory science as degree 

paths, when applicable, as discussed in 

response to comments in section III.C.3. 

of this rule. 

Comment: Several commenters 

supported the proposal to include a 

bachelor’s degree in respiratory therapy 

or cardiovascular technology from an 

accredited institution to the TC 

qualifications for blood gas analysis. 

Additional commenters requested 

clarification on the proposed 

requirement for 2 years of laboratory 

training and experience for TCs that 

earned a bachelor’s degree in respiratory 

therapy or cardiovascular technology 

from an accredited institution. The 

commenter inquired if the 18 months of 

clinical experience acquired during 

respiratory therapy school would count 

towards the required 2 years. The 

commenter stated that requiring an 

additional 6 months of training and 

education may limit hiring respiratory 

therapists (RT) directly from programs. 

The commenter added that if clinical 

rotations during RT school do not count 

toward the required 2 years of 

laboratory training and experience, then 

all newly graduated RTs would be 

prevented from performing blood gas 

analysis which is an essential function 

in the hospital setting. Another 

commenter suggested that instead of 

requiring 2 years of laboratory training 

and experience, RTs must be graduates 

of professionally accredited respiratory 

therapy or pulmonary technology 

programs. The commenter added that 

RTs are sufficiently trained and 

proficient in arterial puncture, blood gas 

collection, analysis, and interpretation, 

ensuring the quality and accuracy of 

collected samples. These commenters 

agreed that blood gas analysis is an 

integral part of emergency and critical 

patient care decision-making that 

requires immediate collection, analysis, 

and results reporting, and stated that the 

proposed changes will prevent newly 

graduated RTs from obtaining the 

necessary experience and will impose 

further strains on hospitals to find 

qualified personnel when there is 

already a severe shortage nationwide. 

Response: The current and proposed 

TC qualifications for a bachelor’s degree 

also require at least 2 years of laboratory 

training or experience or both in 

nonwaived testing in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible. The proposed TC 

qualifications for blood gas analysis 

parallel these requirements by including 

the two-year requirement of laboratory 

training or experience in blood gas 

analysis for a bachelor’s degree in 

respiratory therapy or cardiovascular 

technology from an accredited 

institution. We believe it is important 

for a TC in blood gas analysis to have 

at least 2 years of laboratory training or 

experience to be consistent with the 

qualification requirements for general 

TCs. The 18 months of clinical rotations 

acquired during respiratory therapy or 

pulmonary technology school may 

count towards the requirement for 2 

years of laboratory training and 

experience. 

In this final rule, consistent with our 

proposed and final policy, we are also 

reformatting proposed § 493.1411(b)(3) 

and (4) to clarify that individuals 

qualifying with a traditional doctoral, 

master’s or bachelor’s degrees and those 

qualifying under the new educational 

pathway must all have the required 

years of laboratory training or 

experience. As we discussed in the 

proposed rule, all individuals qualifying 

through an educational pathway must 

also meet training and/or experience 

requirements. 

We are also updating the regulatory 

cross-reference at finalized 

§ 493.1411(b)(3)(i)(B) and (b)(4)(i)(B) for 

consistency with the reformatting of the 

final regulations in this section. 

After consideration of public 

comments, we are finalizing the 

proposed changes to § 493.1411(b), with 

the following modifications: 

• To add medical laboratory science 

where applicable in this section. 

• To reformat the regulations at 

§ 493.1411(b)(3) and (4). 

• To update the regulatory crossreferences at § 493.1411(b)(3)(i)(B) to 

‘‘§ 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or 

(b)(4)(i)(C)’’. 

• To update the regulatory crossreference at § 493.1411(b)(4)(i)(B) to 

§ 493.1405(b)(5)(i)(B). 

7. Testing Personnel Qualifications 

(§ 493.1423) 

We proposed redesignating 

§ 493.1423(b)(2), (3), and (4) as 

§ 493.1423(b)(4), (5), (6), respectively. 

We also proposed separating current 

paragraph (b)(1) into two separate 

provisions. Revised paragraph (b)(1) 

would include the current requirement 

of a doctor of medicine or doctor of 

osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located. New 

paragraph (b)(2) would include the 

requirement of an earned doctoral, 

master’s, or bachelor’s degree in a 

chemical, biological, or clinical 

laboratory science or medical 

technology from an accredited 

institution. As discussed in section 

III.B.17. of the proposed rule, we 

proposed removing an earned doctoral, 

master’s, or bachelor’s degree in 

‘‘physical science’’ as a means to 

qualify. In addition, we proposed 

adding an earned doctoral, master’s, or 

bachelor’s degree in nursing as a means 

to qualify. In Survey and Certification 

memo 16–18–CLIA,22 we stated that ‘‘a 


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bachelor’s in nursing meets the 

requirement of having earned a 

bachelor’s degree in a biological science 

for high complexity TP’’ and that ‘‘an 

associate degree in nursing meets the 

requirement of having earned an 

associate degree in a biological science 

for moderate complexity TP.’’ We stated 

in the proposed rule that we appreciate 

all comments received in response to 

the 2018 RFI and agree that a nursing 

degree is not equivalent to a biological 

or chemical science degree. We further 

stated that we also concur with some 

commenters’ recommendation that 

nursing degrees be used as a separate 

qualifying degree for TP. As testing 

practices and technologies have 

evolved, point of care testing has 

become a standard of practice in many 

health care systems, allowing laboratory 

results to be delivered to the treating 

health care provider as rapidly as 

possible. We recognize that in many 

health care systems, nurses perform the 

majority of the point of care testing in 

many different scenarios (for example, 

bedside, surgery centers, end-stage renal 

disease facilities). We stated that we do 

not have any reason to believe that 

nurses would be unable to accurately 

and reliably perform moderate and high 

complexity testing with appropriate 

training and demonstration of 

competency. 

We proposed adding new paragraph 

(b)(3) to include the requirement that 

the individual must meet the criteria in 

§ 493.1405(b)(3)(ii), (b)(4)(ii), (b)(4)(iii) 

or (b)(5)(ii) (finalized in this final rule 

at § 493.1405(b)(3)(i)(B), (b)(4)(i)(B), 

(b)(4)(i)(C), and (b)(5)(i)(B)) to allow 

individuals who do not have a 

chemical, biological, or clinical 

laboratory science or medical 

technology degree to be eligible to 

qualify as a TP using the educational 

algorithm. See discussion in section 

III.B.3. of the proposed rule. 

In addition, we proposed adding at 

paragraph (b)(7) a requirement to allow 

individuals who perform blood gas 

testing to be qualified under 

§ 493.1423(b)(1) through (4) or have 

earned a bachelor’s degree in respiratory 

therapy or cardiovascular technology 

from an accredited institution or have 

an associate degree related to 

pulmonary function and have at least 2 

years training or experience or both in 

blood gas analysis. We proposed this 

addition so that parity can exist with 

high complexity TP requirements for 

blood gas testing at § 493.1489(b)(6). See 

previous discussion at § 493.1411(b). 

We received public comments on 

these proposals at § 493.1423. The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: Many commenters opposed 

the proposed addition of a nursing 

degree to qualify as testing personnel in 

laboratories that are performing 

moderate complexity testing. Many 

commenters noted that the proposed 

rule stated that responses to the RFI did 

not concur that nursing degrees were 

equivalent to biological or chemical 

sciences degrees, and the majority of the 

commenters on the proposed rule 

agreed, stating that there is very little 

laboratory science coursework in a 

nursing degree program. Commenters 

agree that nursing professionals are 

highly skilled and extremely valuable 

members of the healthcare workforce. 

However, commenters stated their 

education and training do not 

emphasize the skills needed to 

accurately perform moderate and high 

complexity testing, which, by their 

definition, have a higher degree of 

potentially negative impact on the 

patient if performed incorrectly. 

Commenters noted the specific 

laboratory science courses that 

laboratory technicians and medical 

laboratory scientists must complete in 

contrast to the single chemistry course 

required by many nursing degrees. 

Others added that nursing coursework 

does not provide the knowledge to 

understand and correctly perform 

moderate and high complexity testing, 

including the fundamental aspects of 

clinical laboratory testing such as QC, 

delta checks, specimen integrity, 

confounding variables, chemical 

interactors/inhibitors, and many other 

relevant topics required to carry out 

these higher levels of testing accurately. 

Many commenters agreed that POC 

testing is not equivalent to moderate or 

high complexity testing and stated that 

allowing anyone to work in a clinical 

laboratory without the proper training 

will put patients at risk. Many 

commenters provided examples of 

personal situations where an individual 

with a nursing degree was unable to 

accurately perform or understand 

clinical laboratory testing, including 

POC tests. Others commented that both 

nursing and laboratory fields are facing 

national workforce shortages, and 

nursing professionals are already 

overburdened with additional duties. 

Response: We recognize that many 

interested parties do not consider a 

nursing degree equivalent to a chemical, 

biological, clinical or medical laboratory 

science, or medical technology degree. 

However, since 2016, CMS has 

considered nursing degrees equivalent 

to biology degrees. In Survey and 

Certification memo 16–18–CLIA, we 

stated that ‘‘a bachelor’s in nursing 

meets the requirement of having earned 

a bachelor’s degree in a biological 

science for high complexity TP’’ and 

that ‘‘an associate degree in nursing 

meets the requirement of having earned 

an associate degree in a biological 

science for moderate complexity TP.’’ 

As stated in the proposed rule, POC 

testing has become a standard of 

practice in many healthcare systems, 

allowing laboratory results to be 

delivered to the treating healthcare 

provider as rapidly as possible. We 

recognize that in many healthcare 

systems, nurses perform the majority of 

the POC testing in many different 

scenarios (for example, bedside, surgery 

centers, and end-stage renal disease 

facilities). Our experience since 2016 

demonstrates that nurses with 

appropriate training and demonstration 

of competency are able to accurately 

and reliably perform moderate 

complexity testing. We also recognize 

that in response to the RFI, many 

interested parties suggested nursing 

degrees could be used as a separate 

qualifying degree for nonwaived testing 

personnel. We therefore proposed to 

incorporate a pathway for nursing 

degree candidates to qualify as testing 

personnel in laboratories performing 

moderate complexity testing. As with all 

testing personnel, the laboratory 

director is responsible for ensuring that 

before testing patient specimens, all 

personnel have the appropriate training, 

and can demonstrate that they can 

perform all testing operations reliably to 

provide and report accurate results. 

Under this final rule, individuals with 

nursing degrees will only be able to 

qualify for personnel positions listed in 

subpart M when a nursing degree is 

specifically listed in the regulatory 

qualifications. For example, revised 

§ 493.1423 includes nursing degrees for 

moderate complexity testing personnel. 

However, individuals with nursing 

degrees will no longer be able to qualify 

as LDs as nursing is not listed as a 

qualifying degree under revised 

§ 493.1405(b). 

We note that as discussed in the 

proposed rule, our intent is to allow 

individuals already qualified and 

employed in a given personnel capacity 

as of the date of the final rule to 

continue to be qualified under the new 

provisions (that is, grandfathered), 

provided they are continuously 

employed in their position after the 


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effective date. We proposed 

grandfathering provisions at 

§§ 493.1405(b)(6), 493.1411(b)(7), 

493.1443(b)(4), 493.1461(c)(4), 

493.1483(b)(3), and 493.1489(b)(5), but 

inadvertently omitted the applicable 

grandfather provisions in §§ 493.1423 

and 493.1449. We are including those 

provisions in this final rule at 

§§ 493.1423(b)(8) and 493.1449(j), 

respectively. Like the other new 

grandfather clauses, this one allows 

individuals already qualified and 

employed in the applicable personnel 

position as of the effective date of the 

final rule to continue to be qualified 

under the new provisions provided the 

individuals remain continuously 

employed in their position after the 

effective date. 

Comment: A commenter suggested a 

definition for ‘‘blood gas testing’’ to 

indicate if it includes oxygen 

saturations and co-oximetry testing as 

well as to include or exclude venous 

and capillary gases since arterial 

samples are the most common sample 

type but not defined in the proposed 

change. The commenter stated that 

emergency medical technicians need to 

run blood gases during critical patient 

transport and may not qualify as testing 

personnel. The commenter stated that 

critical patients need hands-on lifesaving support and that a trained, 

competent, and experienced high school 

diploma testing personnel should be 

allowed to run a blood gas test in a POC 

device. 

Response: CLIA allows moderate 

complexity testing personnel to qualify 

with a high school diploma or 

equivalent and documented training of 

the testing performed prior to reporting 

patient test results. Individuals who 

meet the regulatory qualifications for 

moderate complexity can perform any 

test categorized by the FDA as moderate 

complexity, including blood gases. No 

change is necessary to the regulations. 

Comment: As discussed in the 

comment section for the proposed 

changes to the technical consultant 

qualifications, several commenters 

requested clarification on the proposed 

requirement for 2 years of laboratory 

training and experience for RTs and 

inquired if the 18 months of clinical 

experience acquired during respiratory 

therapy school would count towards the 

required 2 years. 

Response: The 18 months of clinical 

rotations acquired during respiratory 

therapy or pulmonary technology school 

may count towards the proposed 

requirement for 2 years of laboratory 

training and experience. 

In this final rule, we are also adding 

‘‘laboratory’’ where training is required 

at proposed § 493.1423(b)(6)(ii) and 

(b)(7)(iii)(B) to clarify the type of 

acceptable training, consistent with the 

new definition of ‘‘laboratory training or 

experience’’ at 42 CFR 493.2 and related 

discussion in the July 2022 proposed 

rule at 87 FR 44911–44913 that training 

and experience must be in a CLIA 

laboratory (87 FR 44911–44913). We are 

reformatting § 493.1423(b)(7) to clarify 

that there are three distinct pathways to 

qualify as testing personnel for blood 

gas analysis under this subsection as 

discussed in the July 2022 proposed 

rule (87 FR 44919–44920). We are 

correcting and updating cross-references 

in the regulatory text where necessary 

for consistency with the reformatting of 

the final regulations. 

As previously discussed, we are 

adding the grandfathering clause in this 

final rule at § 493.1423(b)(8). Like the 

other new grandfather clauses, this one 

allows individuals already qualified and 

employed as moderate complexity 

testing personnel as of the effective date 

of the final rule to continue to be 

qualified under the new provisions 

provided the individuals remain 

continuously employed in their position 

after the effective date. 

We are also making technical changes 

in this section of the final regulations to 

enhance consistency. 

After consideration of the comments 

received, we are finalizing the proposed 

provisions at § 493.1423, with the 

following modifications: 

• To include medical laboratory 

science where applicable, as discussed 

previously in this section. 

• To reformat the regulations at 

§ 493.1423(b)(7). 

• To update the regulatory crossreferences at § 493.1423(b)(3). 

• To add ‘‘laboratory’’ where training 

is required as reflected at 

§ 493.1423(b)(6)(ii) and (b)(7)(iii)(B). 

• To add the grandfathering clause in 

the final regulatory text at 

§ 493.1423(b)(8). 

8. Laboratory Director Qualifications 

(§ 493.1443) 

As discussed in section III.B.3. of the 

proposed rule, we proposed to amend 

§ 493.1443(b)(1)(ii) by removing ‘‘or 

possess qualifications that are 

equivalent to those required for such 

certification.’’ Also, as discussed in 

section III.B.3. of the proposed rule, we 

proposed to amend § 493.1443(b)(2) by 

removing the residency requirement at 

paragraph (b)(2)(i) as a means to qualify 

and redesignating at paragraph (b)(2)(ii) 

(which requires the individual to have 

at least 2 years of experience directing 

or supervising high complexity testing). 

In addition, we proposed adding a new 

paragraph (b)(2)(ii), to require 20 CE 

credit hours. (As discussed later in this 

section of the final rule, these 

provisions in the proposed rule at (b)(2) 

are being reformatted and finalized at 

the revised (b)(2)(i) through (iii)). 

We proposed redesignating current 

paragraph (b)(3)(i) as new paragraph 

(b)(3)(iii) and redesignating the 

provisions of paragraphs (b)(2)(ii)(A) 

and (B) as new paragraphs (b)(3)(iv). (As 

discussed later in this section of the 

final rule, these provisions in the 

proposed rule at (b)(3) are being 

reformatted and finalized at the revised 

(b)(3)(i) through (iv)). 

As discussed in section III.B.17 of the 

proposed rule, we proposed 

redesignating the introductory text of 

paragraph (b)(3) as new paragraph 

(b)(3)(i) to revise this paragraph by 

removing an earned doctoral, master’s, 

or bachelor’s degree in ‘‘physical 

science’’ as a means to qualify. As 

discussed in section III.B.8. of the 

proposed rule, we would revise newly 

redesignated paragraph (b)(3)(i) by 

adding an earned doctoral degree in 

‘‘medical technology’’ as a means to 

qualify. (As discussed later in this 

section of the final rule, this provision 

in the proposed rule at (b)(3)(i) is being 

reformatted and finalized at (b)(3)(i)(A)). 

As discussed in section III.B.8 of the 

proposed rule, we proposed adding an 

educational requirement at new 

paragraph § 493.1443(b)(3)(ii) that 

includes a qualification algorithm for an 

individual that does not have an earned 

doctoral degree in a chemical, 

biological, or clinical laboratory science 

or medical technology. As discussed in 

this section of the final rule, this 

provision in the proposed rule at 

(b)(3)(ii) is being reformatted and 

finalized at (b)(3)(i)(B). 

At paragraphs § 493.1443(b)(3)(ii) and 

(b)(4) and (5), we proposed deleting 

these paragraphs to remove the 

grandfather provisions as these 

requirements had to have been met by 

February 24, 2003, March 14, 1990, and 

February 28, 1992, respectively, and 

individuals can no longer qualify under 

these provisions. We proposed adding a 

new paragraph (b)(4) to specify the new 

grandfather provision. We also proposed 

redesignating paragraph (b)(6) as new 

paragraph (b)(5). 

Finally, as discussed in section III.B.3. 

of the proposed rule, we proposed 

adding a 20 CE credit hour requirement 

at new paragraph § 493.1443(b)(3)(v). As 

discussed in this section of the final 

rule, this provision in the proposed rule 

at (b)(3)(v) is being reformatted and 

finalized at (b)(3)(iv). 

We received public comments on 

these proposals at § 493.1443. The 


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following is a summary of the public 

comments we received and our 

responses. 

Comment: Many commenters opposed 

the proposed addition of an educational 

requirement that includes a 

qualification algorithm for an individual 

with a master’s degree equivalency that 

does not have an earned doctoral degree 

in a chemical, biological, or clinical 

laboratory science or medical 

technology to qualify as a high 

complexity laboratory director (HCLD). 

Commenters stated that doctoral-level 

HCLDs are critical in ensuring highquality, appropriate patient care. HCLDs 

are responsible for overseeing all 

clinical and scientific aspects and 

related operational aspects of the 

laboratory. Their responsibilities 

include introducing, developing, 

validating, implementing, and 

interpreting laboratory tests. 

Commenters added that any pathway to 

high complexity laboratory directorship, 

such as the proposed master’s degree 

equivalence that bypasses Ph.D.-level 

training, could jeopardize patient care 

and does not acknowledge the 

importance of scientific and medical 

expertise essential to becoming a 

qualified HCLD. Another commenter 

stated that the limited exposure that a 

master’s degree candidate receives is 

insufficient to serve as an HCLD noting 

that running a high complexity 

laboratory requires critical thinking and 

subject matter expertise. Several 

commenters stated that the master’s 

degree does not provide the rigorous 

research component required by most 

doctoral programs. They indicated that 

research is critical to developing and 

refining the techniques and skills that 

are needed by the HCLD to serve their 

patients. They stated that this research 

component allows the person to think 

independently, identify and 

troubleshoot analytical problems that 

can affect the clinical interpretation, 

and provides them the competencies to 

develop and validate new tests, and 

much more. Another commenter noted 

that HCLDs’ key responsibilities include 

analytical method selection for either 

replacing an outdated methodology or 

introducing a new one; communication 

with peer clinical colleagues and 

effective responses to queries on 

individual laboratory test results; 

producing and updating as needed, 

patient-focused reporting of results that 

make use of established reference ranges 

for distinguishing between normal and 

abnormal results; participation in 

regional, national or international 

discussion panels to review testing 

issues such as QC best practices, 

selection of best performing analytical 

methods; and presentation of studies 

that evaluate the overall clinical 

performance of tests and their 

robustness in practice. The commenter 

stated that master’s degree program 

requirements do not meet the CLIA 

qualifications for a HCLD. The 

commenters opposed the proposed 

lowering of the HCLD qualifications to 

include a master’s equivalency pathway. 

Some commenters stated that a doctorallevel or medical doctor degree should be 

the minimum educational qualification 

for a HCLD, given the importance of the 

role of overseeing the overall 

management of high complexity testing 

and laboratory operations of the clinical 

laboratory. 

Response: We agree with the 

commenters that a medical or doctoral 

degree should be required as the 

minimum educational qualifications for 

a LD in laboratories performing high 

complexity testing. Therefore, we are 

revising § 493.1443(b)(3) as proposed to 

specify that the individual must have an 

earned doctoral degree for purposes of 

the doctoral degree algorithm. The 

current CLIA LD qualifications for 

laboratories performing high complexity 

testing (§ 493.1443) provide a pathway 

for individuals with a doctor of 

medicine, doctor of osteopathy, doctor 

of podiatric medicine, or an earned 

doctoral degree. We agree that this will 

remain unchanged under the final rule. 

Comment: Several commenters 

opposed the proposed inclusion of the 

DCLS as a doctoral degree qualification 

for HCLDs. Commenters stated several 

reasons for their opposition, including 

what they stated was the lack of a 

rigorous research component similar to 

what doctoral programs require. One 

commenter noted that most HCLDs have 

additional post-doctorate fellowship 

experience with rigorous clinical and 

operational training research 

specifically focused on their dedicated 

specialty. They stated that this research 

training is critical to developing and 

refining the techniques and skills an 

HCLD needs to serve their patients, 

including identifying and addressing 

problems affecting clinical 

interpretation and developing and 

validating new tests. Commenters also 

stated that individuals holding a Ph.D. 

have post-doctoral experience in 

laboratory medicine, are board-certified 

and are professionally qualified as an 

HCLD. Commenters indicated that the 

DCLS degree is focused primarily on 

laboratory management with little 

concentration on laboratory testing or 

processes. One commenter was not 

aware of any organization that certifies 

the DCLS candidates as competent in 

laboratory medicine. Commenters also 

noted that an HCLD must have a wide 

range of knowledge in both analytical 

and clinical laboratory medicine and be 

able to teach pathology residents. In 

addition to the scientific 

responsibilities, the administrative 

duties require the HCLD to prepare an 

annual report for the laboratory, comply 

with all the Federal and State 

requirements, negotiate with the 

hospital administration a budget, justify 

new equipment, and hire and keep the 

laboratory staff. Commenters believed 

that individuals with a DCLS do not 

possess the scientific skills to design 

and interpret analytical assays, interpret 

unusual laboratory test results, check for 

interferences in laboratory tests, validate 

and troubleshoot an assay, decide which 

instrument, what automation system 

and what software programs should be 

used in the laboratory, and discuss key 

laboratory and clinical issues with 

clinicians in all fields of medicine. 

Another commenter stated that DCLS 

candidates are not required to pass a 

comprehensive exam before they can 

complete their research and earn the 

degree, nor work as a teaching assistant 

to gain skills needed to give didactic 

lessons to a class and give presentations 

at conferences routinely allowing Ph.D. 

candidates to become competent in 

addressing issues unique to the high 

complexity specialties that are not 

included in DCLS programs. Another 

commenter was concerned that there 

might be confusion among the public 

about the distinctions between a clinical 

pathologist (MD or DO) and a DCLS, 

emphasizing that pathologists (MD or 

DO) are licensed physicians who are 

trained in pathology to make medical 

diagnoses and that by their clinical 

training, including medical school and 

graduate medical education, and 

specialty certification in the medical 

disciplines of anatomic and clinical 

pathology, pathologists are uniquely 

best qualified to perform HCLD 

responsibilities. Commenters added that 

individuals with DCLS degrees need a 

more scientific and clinical background 

to participate in patient care. The 

commenters believed that finalizing the 

proposed DCLS qualification for HCLDs 

will increase the potential for patient 

harm. 

In contrast, we also received many 

comments in support of the proposed 

recognition of the DCLS as a recognized 

doctoral degree to qualify as an HCLD. 

As noted by many commenters, the 

DCLS is the only doctorate whose 

primary specific focus is clinical 

laboratory testing. These commenters 

stated that it is the only degree based on 


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uniform clinical laboratory testing 

accreditation standards with National 

Accrediting Agency for Clinical 

Laboratory Sciences (NAACLS) 

accreditation. Commenters noted that 

currently, there are three DCLS 

programs in the U.S., and each requires 

laboratory experience (at least 3 years) 

before admission to the doctoral 

program. The commenters stated that 

the ASCP Board of Certification has 

committed to offering certification for 

the DCLS and that multiple DCLS 

graduates have already been boardcertified as HCLDs by other HHSapproved certification boards, such as 

the National Registry of Certified 

Chemists (NRCC). Many commenters 

expressed that statements received from 

several laboratory professional 

organizations opposing the proposal to 

include DCLS as HCLD were not based 

on facts about the DCLS programs. 

Commenters added that as indicated in 

the American Society for Clinical 

Laboratory Science (ASCLS) DCLS Body 

of Knowledge (BOK), an individual with 

a DCLS increases diagnostic efficiency, 

facilitates patient management 

outcomes, and improves timely access 

to accurate and appropriate laboratory 

information by participating directly in 

patient care decisions, monitoring 

laboratory utilization, and conducting 

research on the diagnostic process. The 

commenters stated that the BOK also 

outlines professional practice activities 

related to the five core competencies 

and the foundational knowledge 

required for professional practice. A 

commenter stated that no evidence had 

been provided that the DCLS is 

substandard or would be less qualified 

than current eligible doctorates in this 

role. The commenter stated that the 

argument that a Ph.D.-like dissertation 

is not required of the DCLS is irrelevant 

since most professional doctorates opt 

instead for the more important extensive 

capstone laboratory science experience, 

culminating in a rigorous scholarly 

investigation on a relevant topic 

defended before a doctoral committee. 

Completing components in the 

advanced education of laboratory 

sciences, research, and residency is 

required for DCLS graduation. A 

commenter stated that completing the 

research component of DCLS training 

results in graduates who can translate 

research and evidence into best 

practices and design their research 

projects to improve patient care goals. 

DCLS graduates are required to 

complete institutional review boardapproved research for the fulfillment of 

their degree. The DCLS is typically 

trained in more than one clinical 

laboratory area (for example, 

microbiology, chemistry, hematology, 

etc.), which helps understand the 

interrelatedness of laboratory test 

results. According to the commenters, 

the DCLS curriculum includes 

diagnostics, assay development, test 

interpretation, treatment, problemsolving, quality control, and statistical 

analysis, all critical elements of HCLD 

roles. Commenters further stated that 

contrary to some of the opposition 

expressed, the DCLS has significant 

experience in a clinical laboratory, and 

whether it is considered an advanced 

practice or entry-level degree makes 

little difference if the qualifications, 

competencies, and experiences are in 

place. Another supporting commenter 

added that the proposed inclusion of 

DCLS as HCLD will positively impact 

workforce shortages by establishing 

legal legitimacy for advanced practice 

and improving recruitment and 

retention of skilled laboratorians to the 

workforce. Several commenters noted 

direct experience mentoring or working 

alongside DCLS graduates during their 

clinical residency and noted that DCLS 

graduates provided expert analysis of 

enterprise-wide laboratory test 

utilization, proposed interventions to 

change clinical and operational 

practices to optimize test use, 

contributed to multidisciplinary 

decision-making in test stewardship and 

other laboratory quality initiatives, 

provided consultation for optimizing 

information management, and provided 

direct laboratory test consultation to 

healthcare providers in surgical and 

medical intensive care units. Multiple 

commenters added that the DCLS 

practitioner is uniquely qualified to 

serve in multiple roles, including that of 

HCLD, because of their broad and 

advanced knowledge and training across 

all disciplines of the clinical laboratory 

(for example, hematology, hemostasis, 

immunohematology, clinical chemistry, 

microbiology) as opposed to the limited 

scope of one clinical discipline in some 

Ph.D. training programs. Another 

commenter added that the DCLS’s 

knowledge also provides for developing 

clinical and reflex test pathways and 

consultation services that provide 

knowledge to physicians for better 

patient management and test ordering as 

well as for decreasing costs. One 

commenter noted published article(s) 

demonstrated laboratory workforce 

shortages, professional burnout, and low 

salary and job satisfaction rates and 

suggested a leadership pathway such as 

the DCLS could help address these 

workforce challenges. Another 

commenter added that including the 

DCLS as HCLDs is the logical step for 

career growth for laboratorians. The 

commenter stated that the technical and 

scientific expertise of the highly driven 

laboratory scientist is often lost to 

nursing programs, physician assistant 

programs, medical schools, managerial 

roles relating to business goals, and 

industry positions. One commenter 

noted the potential benefits of allowing 

DCLS holders to serve as HCLDs, 

particularly in rural/small hospitals and 

reference laboratories that may not be 

able to afford an on-site pathologist or 

whose volume does not warrant the 

need for an on-site pathologist. The 

commenter stated that such underserved 

laboratories/facilities stand to gain by 

being allowed to hire DCLS graduates as 

HCLDs, who can serve not only in the 

capacity of CLIA director but also 

oversee the day-to-day administrative/ 

supervisory functions. Commenters 

agreed that with a strong background in 

clinical science, research, quality 

management, and cross-functional 

collaboration, the DCLS professional 

can positively impact the quality of 

patient care provided while improving 

healthcare efficiency. According to 

these commenters, the DCLS fills a 

much-needed gap in our healthcare 

system and will dramatically enhance 

and promote quality patient care while 

being a valuable healthcare team 

member. 

Response: The current HCLD 

qualifications under § 493.1443(b)(3) 

states that the LD must hold an earned 

doctoral degree in a chemical, physical, 

biological, or clinical laboratory science 

from an accredited institution. In this 

final rule, we define ‘‘doctoral degree’’ 

to clarify what we mean by the term and 

to include the DCLS as an acceptable 

doctoral degree. Our experience under 

the prior regulations demonstrates that 

board-certified DCLS graduates are 

prepared to serve as HCLDs. As stated 

in the proposed rule, we agree that 

individuals with a DCLS are experts in 

clinical laboratory testing. We consider 

a DCLS an acceptable doctoral degree. 

Comment: A commenter suggested 

that HCLDs should also be certified at 

a doctoral level in the applicable 

subdisciplines through the appropriate 

board (that is, American Board of 

Medical Microbiology) or in addition to 

physician (MD or DO) certification in 

anatomic or clinical pathology. 

Response: HCLDs must be qualified to 

manage and direct laboratory personnel 

and performance of high complexity 

testing. HCLDs qualifying as MDs or 

DOs must be certified in anatomic or 

clinical pathology, or both, or have 

appropriate experience directing or 

supervising high complexity testing. 


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The current and proposed qualifications 

for an HCLD with a doctoral degree 

include certification by a board 

approved by HHS. Both pathways 

require only one board certification. For 

example, if a HCLD is certified by the 

American Board of Pathology, we do not 

require additional certification in a 

subspecialty. 

Comment: A commenter suggested 

that in addition to an earned doctoral 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology from an accredited 

institution, there should be a 

requirement for a completed doctoral 

dissertation in subjects related to 

laboratory testing for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

the health of human beings. The 

commenter stated that such a 

requirement would ensure that 

individuals who serve as LDs in 

laboratories performing high complexity 

testing have in-person, practical handson laboratory training and experience 

managing complex clinical testing and 

operations, ultimately ensuring highquality patient care and safety. 

Response: The current and proposed 

qualifications for an HCLD with a 

doctoral degree include certification by 

a board approved by HHS. Board 

certification and the doctoral degree 

together ensure the technical 

competence of medical laboratory 

professionals. 

Comment: A commenter suggested 

that the grandfather clause(s) be 

retained in the final rule as that 

information is useful when determining 

if an individual qualifies under those 

routes. 

Response: We proposed to remove the 

current grandfather clauses and add a 

new clause to indicate that an 

individual is considered qualified as a 

LD of high complexity testing under this 

section if they were qualified and 

serving as a LD of high complexity 

testing in a CLIA-certified laboratory as 

of the effective date of this final rule and 

have done so continuously since the 

effective date of this final rule. Also, we 

added this clause to other applicable 

sections, as proposed. Prior versions of 

the CFR are available free online at 

https://www.govinfo.gov/app/collection/ 

cfr. 

Comment: A commenter noted that 

the language in the proposed 

grandfather clauses indicated that they 

qualify only if they serve continuously 

in their position after the final rule’s 

effective date. The commenter stated 

that this defeats CMS’s stated intent to 

increase the number of eligible 

candidates needed to perform laboratory 

testing and is grossly unfair to 

individuals who qualify under a 

grandfathering provision and then suffer 

a break in service of even one day (for 

example, due to illness, family 

emergency, or sale of their laboratory) 

after the final rule is published. The 

commenter requested a revision to allow 

breaks in service (for example, 3 years) 

before an individual had to requalify. 

Response: The new provision will 

allow individuals qualified for specific 

personnel roles to continue serving in 

those roles as long as they have 

continued to perform those duties. The 

updates to the CLIA personnel 

requirements in this final rule provide 

additional pathways for individuals to 

qualify as personnel for both moderate 

and high complexity testing. 

Clarification regarding continuous 

service will be added to updated 

guidance. 

In this final rule, we are also 

reformatting proposed § 493.1443(b)(2) 

to enhance consistency. Consistent with 

our proposed and final policy, we are 

also reformatting proposed 

§ 493.1443(b)(3) to clarify that both

individuals qualifying with traditional

doctoral degrees and those qualifying

under the new educational pathway

must have the specified 20 CE credit

hours, certification, and experience. As

we explained in the July 2022 proposed

rule (87 FR 44910–44911, 44920), 20 CE

credit hours are required to qualify as an

LD and individuals qualifying through

an educational pathway must also have

the required training or experience. In

addition, as in the existing

§ 493.1443(b)(3), individuals qualifying

through this subsection must also have

the required certification.

We are making technical changes in 

this section of the regulatory text to 

enhance consistency. 

We are also adding ‘‘approved’’ to the 

final regulatory text at 

§ 493.1443(b)(3)(i)(B)(2) to clarify that if

individuals are qualifying based on a

thesis or research project, that thesis or

research project must be approved,

meaning the individuals must have

received credit for it as reflected on

their transcript. CMS’s policy is to

verify educational qualifications by

reviewing transcripts, as described in its

Survey and Certification Memorandum

16–18–CLIA, Personnel Policies for

Individuals Directing or Performing

Non-waived Tests at 2–4 (April 1, 2016),

available at https://www.cms.gov/

medicare/provider-enrollment-andcertification/surveycertificationgeninfo/

policy-and-memos-to-states-andregions-items/survey-and-cert-letter-16-

18.

After consideration of the comments 

received, we are finalizing the proposed 

changes to § 493.1443(b) with the 

following modifications: 

• To include medical laboratory

science as discussed previously in 

sections III.B.1. (§ 493.2) and III.B.3 

(§ 493.1405) and to clarify the doctoral

degree algorithm by specifying that an

individual must hold an earned doctoral

degree.

• To reformat § 493.1443(b)(2) and

(3). 

• To add ‘‘approved’’ as reflected at

§ 493.1443(b)(3)(i)(B)(2).

9. Laboratory Director Responsibilities

(§ 493.1445)

For proposals related to § 493.1445,

please see the discussion in this final 

rule at sections III.B.5: Laboratory 

director responsibilities for Laboratories 

Performing Moderate Complexity 

Testing (§ 493.1407). 

We summarized the public comments 

related to on-site visits for purposes of 

both proposed revised § 493.1407 and 

proposed revised § 493.1445 in this final 

rule at section III.B.5: Laboratory 

Director Responsibilities for 

Laboratories Performing Moderate 

Complexity Testing (§ 493.1407). 

After consideration of the comments 

received, we are finalizing the proposed 

changes to § 493.1445(c). In this final 

rule, we are also correcting and 

updating the regulatory cross-reference 

in the current regulations at 

§ 493.1445(e)(10) from § 493.1489(b)(4)

to § 493.1489(b)(5) for consistency with

the finalized regulations.

10. Technical Supervisor Qualifications

(§ 493.1449)

At § 493.1449, we proposed

combining the provisions of paragraphs 

(c) through (g) into new paragraph (c)

and combining paragraphs (h) through

(j), (n), and (q) into a new paragraph (d).

We also proposed redesignating

paragraphs (k), (l), (m), (o), and (p) as

paragraphs (e), (f), (g), (h), and (i),

respectively. We proposed these

changes to simplify the regulations by

reducing confusion and grouping

identical TS requirements into a

combined provision. We also proposed

to insert the education algorithm at

paragraph (c)(4)(i)(B).

At newly redesignated paragraph 

(e)(1)(ii), we proposed to remove the 

language at existing paragraph 

(k)(1)(ii)(B) since the American Society 

of Cytology has not provided 

certification for cytology since 1998; 

certification is provided by American 

Board of Pathology and American Board 

of Osteopathic Pathology. 


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23https://www.ascp.org/content/docs/defaultsource/boc-pdfs/exam-content-outlines/ascp-bocus-procedures-book-web.pdf. 

At newly redesignated paragraph (d) 

(formerly paragraph (q)), we proposed 

amending the immunohematology 

requirement for the TS requirement to 

align with other TS qualifications and 

allow individuals with doctoral, 

master’s, and bachelor’s degrees with 

appropriate training and experience to 

qualify as a TS for immunohematology. 

This provision will be included in 

§ 493.1449(d). The current regulation

requires that the TS for

immunohematology be a doctor of

medicine or osteopathy. Fulfilling the

CA requirements (for example, direct

observation) can be challenging in rural

facilities as the TS may not be onsite as

the individual(s) may cover a large

geographic area. Often a MT/CLS with

a SBB (Specialist in Blood Bank) from

ASCP (The American Society for

Clinical Pathology) 23 is on-site to

oversee the day-to-day operations of the

blood bank. By allowing qualified

individuals with doctoral, master’s, or

bachelor’s degrees, to qualify as TSs, the

personnel responsibilities will align

with the current practices in

laboratories without affecting the ability

of the laboratory to provide accurate and

reliable results. Further, the proposed

change may help alleviate a shortage of

physicians in rural areas and does not

constitute a risk to public health or the

individuals served by the laboratory.

As discussed in section III. B.16. of 

the proposed rule, we proposed at 

§ 493.1449 to remove an earned

doctoral, master’s, or bachelor’s degree

in ‘‘physical science’’ as a means to

qualify.

We received public comments on 

these proposals at § 493.1449. The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: One commenter opposed 

the proposal to include qualification 

pathways for master’s and bachelor’s 

degree candidates to qualify as TSs in 

laboratories that perform testing in the 

specialty of immunohematology. The 

commenter stated that the 

immunohematology field is evolving 

into emerging uses such as hazards of 

therapies (for example, cellular therapy) 

in transfusion medicine, which require 

the expertise of a physician to oversee. 

Another commenter stated that the high 

risk associated with a mistake in 

immunohematology could cost a patient 

their life. Another commenter suggested 

removing a master’s or a bachelor’s 

degree as an equivalency to individuals 

with an MD, DO, Doctor of Podiatric 

Medicine (DPM), or an earned Ph.D. in 

chemical, biological, or clinical 

laboratory science or medical 

technology in the subspecialty of 

bacteriology, mycobacteriology, 

mycology, parasitology, or virology as 

delineated in paragraph (c)(4), and the 

subspecialty of diagnostic immunology, 

chemistry, hematology, radiobioassay, 

or immunohematology, as delineated in 

paragraph (d)(4). The commenter stated 

that the breadth and depth of 

experience, training, critical thinking, 

and analytical skillset acquired from a 

master’s or bachelor’s degree, are 

considerably lower and notably less 

stringent than those obtained from a 

traditional doctoral degree and 

maintaining the current CLIA 

qualifications related to MD, DO, DPM, 

and doctoral degree would be consistent 

with the requirements for certification 

by all nine HHS-approved certification 

boards. 

Response: The current CLIA 

regulations provide qualification 

pathways for master’s and bachelor’s 

degrees for the subspecialties of 

bacteriology, mycobacteriology, 

mycology, parasitology, and virology 

and the specialties of diagnostic 

immunology, chemistry, hematology, 

and radiobioassay. We proposed to 

amend the immunohematology 

requirement to align with other TS 

qualifications and allow individuals 

with doctoral, master’s, and bachelor’s 

degrees with appropriate training and 

experience to qualify as a TS for 

immunohematology. As noted in the 

proposed rule, fulfilling the CA 

requirements (for example, direct 

observation) can be challenging in rural 

facilities. A physician or doctoral-level 

TS may not be onsite as the 

individual(s) may cover a large 

geographic area. Allowing qualified 

individuals with doctoral, master’s, or 

bachelor’s degrees to qualify as TSs will 

align with the current practices in 

laboratories without affecting the ability 

of the laboratory to provide accurate and 

reliable results. 

In this final rule, consistent with our 

proposed and final policy, we are also 

reformatting proposed § 493.1449(c)(3), 

(4), and (5) and § 493.1449(d)(3), (4), 

and (5) to clarify that individuals 

qualifying with a traditional doctoral, 

master’s or bachelor’s degree and those 

qualifying under the new educational 

pathway must all have the required 

years of laboratory training or 

experience. As we explained in the July 

2022 proposed rule (87 FR 44911), the 

requirement for laboratory training and/ 

or experience applies to all individuals 

qualifying through an educational 

pathway. We are also reformatting 

proposed § 493.1449(h) to clarify that 

there are two pathways to qualify under 

this subsection. Those pathways were 

designated (h)(1) and (h)(1)(i) in the 

proposed regulation text and are being 

finalized as (h)(1) and (2). 

We are making technical changes in 

the finalized regulatory text to enhance 

consistency. Specialty/subspecialty 

headers were also added to the 

regulatory text to identify each of the 

specialty/subspecialty sections. CMS is 

also correcting and updating crossreferences in the finalized regulatory 

text where necessary for consistency 

with the reformatting of the finalized 

regulations or to correct technical errors. 

In this final rule, at 

§ 493.1449(c)(4)(i)(C)(2) we are revising

to clarify that, under this educational

pathway, 16 semester hours in a

combination of graduate level

coursework in the specified subjects and

a thesis or research project related to

CLIA laboratory testing is required and

that, if an individual is qualifying based

on a thesis or research project, that

thesis or research project must be

approved, meaning the individual must

have received credit for it as reflected

on their transcript. CMS’s policy is to

verify educational qualifications by

reviewing transcripts, as described in its

Survey and Certification Memorandum

16–18–CLIA, Personnel Policies for

Individuals Directing or Performing

Non-waived Tests at 2–4 (April 1, 2016),

available at https://www.cms.gov/

medicare/provider-enrollment-andcertification/surveycertificationgeninfo/

policy-and-memos-to-states-andregions-items/survey-and-cert-letter-16-

18.

We are adding ‘‘laboratory’’ where 

training is required at § 493.1449(i)(1) 

and (i)(2) in this final rule to clarify the 

type of acceptable training, consistent 

with the new definition of ‘‘laboratory 

training or experience’’ at 42 CFR 493.2 

and related discussion in the July 2022 

proposed rule that training and 

experience must be in a CLIA laboratory 

(87 FR 44911–44913). 

As previously discussed in section 

III.B.7 of this final rule, we are also

adding the grandfathering clause in the

final regulatory text at § 493.1449(j).

Like the other new grandfather clauses,

this one allows individuals already

qualified and employed as high

complexity technical supervisors as of

the effective date of the final rule to

continue to be qualified under the new

provisions provided the individuals

remain continuously employed in their

position after the effective date.

After consideration of the comments 

received, we are finalizing the proposed 


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90018 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

changes at § 493.1449, with the 

following modifications: 

• To include medical laboratory 

science as discussed previously in 

sections III.B.1. (§ 493.2) and III.B.3. 

(§ 493.1405) of this final rule. 

• To revise the regulatory text at 

§ 493.1449(c)(4)(i)(C)(2) as described 

previously. 

• To reformat § 493.1449(c)(3), (4), 

and (5), (d)(3), (4), and (5), and (h). 

• To revise the regulatory crossreference at § 493.1449(c)(3)(i)(B) to 

§ 493.1443(b)(3)(i)(B) for consistency 

with the reformatting of the final 

regulations. 

• To revise the regulatory crossreference at § 493.1449(d)(3)(i)(B) to 

§ 493.1443(b)(3)(i)(B) for consistency 

with the reformatting of the final 

regulations. 

• To revise the regulatory crossreference at § 493.1449(d)(4)(i)(B) to 

§ 493.1449(c)(4)(i)(B) and 

§ 493.1449(c)(4)(i)(C) for consistency 

with the reformatting of these final 

regulations. 

• To revise the regulatory crossreference at § 493.1449(d)(5)(i)(B) to 

§ 493.1449(c)(5)(i)(B) for consistency 

with the reformatting of the final 

regulations. 

• To revise the regulatory crossreference at § 493.1449(e)(2) to 

paragraph (e)(1) for consistency with the 

final regulations. 

• To revise the regulatory crossreference at § 493.1449(f)(1)(ii) to 

paragraph (f)(1)(i)(B) for consistency 

with the final regulations. 

• To revise the regulatory crossreference at § 493.1449(f)(2)(ii) to 

paragraph (f)(2)(i)(B) for consistency 

with the final regulations. 

• To revise the regulatory crossreference at § 493.1449(f)(3)(ii) to 

paragraph (f)(3)(i)(B) to include both 

certification pathways in 

§ 493.1449(f)(3)(i)(B). 

• To revise the regulatory crossreference at § 493.1449(g)(3) to 

paragraph (g)(1) for consistency with the 

final regulations. 

• To revise the regulatory crossreference at § 493.1449(h)(2)(i) to 

§ 493.1443(b)(3)(i)(B) for consistency 

with the reformatting of the final 

regulations. 

• To add ‘‘laboratory’’ where training 

is required at § 493.1449(i)(1) and (2). 

• To add ‘‘or’’ to the revised 

regulatory text at § 493.1449(i)(2)(i), 

clinical cytogenetics, to clarify the two 

pathways under this regulation. 

• To add specialty/subspecialty 

headers in the regulations at 

§ 493.1449(c) through (i) to identify each 

of the specialty/subspecialty sections. 

• To update the regulatory crossreference of ‘‘paragraph (h)’’ at 

§ 493.1449 in the regulatory text ‘‘Note 

1’’ to ‘‘paragraphs (b) through (i)’’ 

because Note 1 applies to paragraphs (b) 

through (i), not just (h). 

• To add the grandfathering clause to 

the final regulatory text at § 493.1449(j). 

11. General Supervisor Qualifications 

(§ 493.1461) 

As discussed in section III.B.17. of the 

proposed rule, we proposed at 

§ 493.1461(c)(1)(i) to remove an earned 

doctoral, master’s, or bachelor’s degree 

in ‘‘physical science’’ as a means to 

qualify. At § 493.1461(c)(3) through (5), 

we proposed deleting the grandfather 

provisions as these requirements had to 

have been met by February 28, 1992, 

April 24, 1995, and September 1, 1992, 

respectively, and individuals can no 

longer qualify under these provisions. 

We stated that we plan to grandfather all 

individuals qualified under this 

provision. We also proposed adding 

new paragraph (c)(4) to specify a new 

grandfather provision for those 

individuals who had qualified prior to 

the publication of the final rule. 

We received public comments on 

these proposals at § 493.1461. The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: A commenter stated that 

personnel qualifications do not 

recognize individuals with MLT or MT, 

and there is a need to ensure that 

individuals without associate degrees 

have pathways to qualify as a GS. The 

commenter noted the current CLIA 

exception allowing qualification by 

passing grade in a proficiency 

examination as indicated at 

493.1461(c)(3)(ii). 

Response: The current and proposed 

regulations for TP under § 493.1489 

provide a pathway for individuals to 

qualify through education and training 

without possessing an earned associate 

degree. For example, if an individual is 

qualified as TP under § 493.1489(b)(3) 

as revised; and has at least 2 years of 

laboratory training or experience in high 

complexity testing, they will qualify as 

a GS. 

In this final rule, we are also 

correcting and updating the regulatory 

cross-references in the current 

regulations at § 493.1461(e)(2) and (3) 

for consistency with the finalized 

regulations. 

After consideration of the comments 

received, we are finalizing the proposed 

changes to § 493.1461(c) through (e), 

with the following modifications: 

• To include medical laboratory 

science at § 493.1461(c)(1). 

• To update the regulatory crossreference at § 493.1461(e)(2) from 

‘‘§ 493.1449(l) or (2)’’ to § 493.1449(f)(2). 

• To update the regulatory crossreference at § 493.1461(e)(3) from 

§ 493.1449(l)(3) to § 493.1449(f)(3). 

12. General Supervisor Qualifications 

on or Before February 28, 1992 

(§ 493.1462) 

At § 493.1462, we proposed removing 

the grandfather provision as this 

requirement must have been met by 

February 28, 1992. We stated that these 

individuals would be included in the 

new grandfather provision at 

§ 493.1461(c)(4). 

We received public comments on 

these proposals at § 493.1461(c)(4). The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: A commenter was 

concerned that the proposed changes to 

GS would affect current GSs who 

qualified under the § 493.1462 

grandfather clause. 

Response: We plan to grandfather 

individuals qualified under § 493.1462 

under the new provision 

§ 493.1461(c)(4). We are finalizing a new 

paragraph (c)(4) that will consider an 

individual qualified as a GS if they were 

qualified and serving as a GS in a CLIAcertified laboratory as of the effective 

date of the final rule and have done so 

continuously since the effective date of 

the final rule. 

After consideration of the comments 

received, we are finalizing the removal 

of § 493.1462. 

13. General Supervisor Responsibilities 

(§ 493.1463) 

At § 493.1463(b)(4), we proposed 

revising the language stating the need to 

annually evaluate and document the 

performance of all testing personnel to 

now require the evaluation and 

documentation of the competency of all 

testing personnel. Historically, CLIA has 

allowed the TS to delegate all CA to the 

GS. However, the current regulations 

only speak to the ability of the GS to 

perform annual CA. We clarified that 

the LD or TS may delegate both the 

semi-annual and the annual CA. 

We received public comments on 

these proposals at § 493.1463. The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: A commenter requested 

that the responsibilities specified in 

§ 493.1463(b)(4) be further clarified to 

articulate that GSs in a laboratory that 

performs both high and moderate 

complexity testing are qualified to 

assess the competency of both high 


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complexity TP and moderate 

complexity TP. The commenter stated 

that the term ‘‘all personnel’’ in the rule 

is ambiguous because the GS is a 

position included in the personnel for 

laboratories performing high complexity 

testing and can oversee CA for high 

complexity TP. The commenter noted 

that moderate complexity testing could 

also be performed in a high complexity 

laboratory with a GS, and the GS should 

be able to perform CA on TP performing 

moderate complexity testing. 

Response: The proposal under 

§ 493.1463(b)(4) pertains to all TP, 

including those performing moderate 

complexity tests. This allows GSs in 

laboratories that perform both moderate 

and high complexity testing to perform 

the CA on both moderate and high 

complexity testing personnel. The CMS 

SOM, Appendix C will be updated. 

After consideration of the comments 

received, we are finalizing the proposed 

changes to § 493.1463 without 

modification. 

14. Cytotechnologist Qualifications 

(§ 493.1483) 

At §§ 493.1483(b)(2) and 

493.1489(b)(2)(ii)(B)(1), we proposed to 

replace ‘‘CAHEA’’ with CAAHEP 

(Commission on Accreditation of Allied 

Health Education Programs) and to 

remove, ‘‘or other organization 

approved by HHS.’’ In October 1992, the 

American Medical Association (AMA) 

announced its intent to support the 

establishment of a new and independent 

agency to assume the accreditation 

responsibilities of the Commission on 

Allied Health Education Accreditation 

(CAHEA), which is CAAHEP. HHS has 

no approval process for programs not 

approved or accredited by the 

Accrediting Bureau of Health Education 

Schools (ABHES) or CAAHEP. 

At § 493.1483(b)(3) through (5), we 

proposed removing the grandfather 

provisions as these requirements had to 

have been met by September 1, 1992, or 

September 1, 1994, as individuals can 

no longer qualify under these 

provisions. We stated that we plan to 

grandfather all individuals qualified 

under this provision prior to the date of 

the final rule. These individuals would 

be included in the new grandfather 

provision at § 493.1483(b)(3). 

We did not receive public comments 

on this provision, and are finalizing the 

proposed changes to § 493.1483. In this 

final rule, we are also correcting and 

updating the regulatory cross-reference 

in the introductory text of the current 

regulations at § 493.1483, from 

§ 493.1449(k) to § 493.1449(e), for 

consistency with the finalized 

regulations. 

15. Testing Personnel Qualifications 

(§ 493.1489) 

We proposed removing paragraph 

(b)(3) as the February 28, 1992, 

grandfather provision must have been 

met by February 28, 1992. We also 

proposed redesignating paragraphs 

(b)(2)(i) and (ii) to paragraphs (b)(3)(i) 

and (ii), respectively. As noted, at 

§ 493.1489(b)(3)(ii)(B)(1), we proposed 

replacing ‘‘CAHEA’’ with ‘‘CAAHEP’’ 

and removing ‘‘or other organization 

approved by HHS.’’ 

In addition, we proposed revising 

paragraph (b)(1) to separate the 

provisions into two paragraphs (that is, 

paragraph (b)(1) and new paragraph 

(b)(2)(i)). New paragraph (b)(1) would 

include the current requirement of a 

doctor of medicine or doctor of 

osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located. New 

paragraph (b)(2)(i) would include an 

earned doctoral, master’s, or bachelor’s 

degree in a chemical, biological, or 

clinical laboratory science or medical 

technology from an accredited 

institution. As discussed in section 

III.B.17. of the proposed rule, we 

proposed removing an earned doctoral, 

master’s, or bachelor’s degree in 

‘‘physical science’’ as a means to 

qualify. We proposed adding an earned 

doctoral, master’s, or bachelor’s degree 

in nursing as a means to qualify. In 

addition, we proposed adding new 

paragraph (b)(2)(ii) to state who may be 

qualified under § 493.1443(b)(3) or 

§ 493.1449(c)(4) or (5) to allow 

individuals who do not have a 

chemical, biological, or clinical science 

or medical technology or clinical 

laboratory science degree to be eligible 

to qualify as a TC using the educational 

algorithm. 

At § 493.1489(b)(4), we proposed 

amending this requirement by moving 

the military provision out of the April 

24, 1995, grandfather provision and 

making it a mechanism that individuals 

will be able to qualify for moderate 

complexity testing (§ 493.1423(b)(3)). 

We believe these individuals have the 

requisite educational background to 

meet the requirements to perform 

laboratory testing under CLIA. In 

addition, we proposed removing 

paragraph (b)(4) introductory text and 

paragraph (b)(4)(i) [the text that 

currently states ‘‘On or before’’ through 

‘‘graduated from a [ML] or [CL] training 

program approved or accredited by 

ABHES, CAHEA, or other organizations 

approved by HHS’’] per the discussion 

under § 493.1483(b)(2). As a result, the 

current military requirement at 

paragraph (b)(4)(ii) would be 

redesignated as paragraph (b)(4). 

We received public comments on 

these proposals at § 493.1489. The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: Over 19,000 commenters 

provided a standardized ‘‘form letter’’ 

comment opposing the inclusion of 

nursing degrees (bachelor’s and up) in 

the CLIA high complexity testing 

personnel requirements. In addition to 

the duplicate comments, we received 

many comments related to the inclusion 

of nursing degrees for high complexity 

testing personnel qualifications. The 

commenters stated that nursing degrees 

provide only a fraction of the academic 

science and little, if any, of the clinical 

training in non-waived laboratory 

testing that is required to qualify 

laboratory professionals. Bachelor’s 

degrees in medical laboratory science, 

biology, and chemistry generally require 

at least 35–45 SH of academic science, 

with significant upper-level coursework. 

Commenters stated that in contrast, 

bachelor’s degrees in nursing often 

require less than 14 SH in biology and/ 

or chemistry, and usually only at the 

introductory level. 

Response: After consideration of the 

public comments, we are not finalizing 

the proposed addition of a nursing 

degree in the revised § 493.1489(b)(2)(i) 

as a qualification for high complexity 

laboratory testing personnel. High 

complexity laboratory testing requires a 

higher level of knowledge; training and 

experience; troubleshooting and 

equipment maintenance skills; and 

interpretation and judgement than 

moderate complexity testing. 

Knowledge includes, but is not limited 

to, preanalytic, analytic and 

postanalytic phases of testing, 

calibration, quality control, and 

proficiency testing. We agree with the 

commenters that this knowledge and 

experience may not be obtained in the 

nursing curriculum despite its science 

course requirements. We believe that 

individuals with biological or chemical 

science degrees, clinical laboratory 

science, medical technology, and 

medical laboratory science have a better 

knowledge base for high complexity 

testing. Nurses who have the 

appropriate science courses and training 

may still qualify under 

§ 493.1489(b)(2)(ii) and will be 

evaluated on a case-by-case basis. When 

performing an analysis of all the 

comments received, several additional 

themes emerged, including the lack of 

laboratory training that nursing 

professionals acquire, the additional 

burden that nurses would incur by 


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performing high complexity testing, the 

concern for patient safety, and the 

differences between POC testing (which 

is classified as waived or moderate 

complexity testing only) and high 

complexity testing. Beginning with the 

effective date of this final rule, 

individuals with nursing degrees will 

only be able to qualify for personnel 

positions listed in subpart M when a 

nursing degree is specifically listed in 

the regulatory qualifications. Nursing 

degrees will qualify under moderate 

complexity testing personnel. However, 

individuals with nursing degrees will 

no longer be able to qualify as high 

complexity testing personnel. All 

individuals, including those with 

nursing degrees, who are currently in 

positions listed in subpart M prior to the 

effective date of the final rule will be 

grandfathered as long as they meet the 

applicable grandfather provision, 

including the requirement for 

continuous employment in their 

position since the effective date of the 

final rule. 

Comment: A commenter requested to 

revise § 493.1489 to add ‘‘or’’ at the end 

of paragraph (6)(i) to be consistent with 

similar proposed changes elsewhere in 

the proposed rule. 

Response: We agree with the 

commenter and will amend 

§ 493.1489(b)(6)(i). 

In this final rule, we are also updating 

the regulatory cross-reference at 

§ 493.1489(b)(7) for consistency with the 

finalized regulations. 

After consideration of the comments 

received, we are finalizing the proposed 

changes to § 493.1489(b) with the 

following modifications: 

• To include medical laboratory 

science at § 493.1489(b)(2)(i), consistent 

with similar changes as discussed 

elsewhere in this final rule, and to 

remove the proposed addition of a 

nursing degree at § 493.1489(b)(2)(i). 

• To add ‘‘or’’ at the end of 

§ 493.1489(b)(6)(i). 

• To update the regulatory crossreference at § 493.1489(b)(7) from 

§ 493.1449(l) to § 493.1449(f) for 

consistency with the finalized 

regulations. 

16. Technologist Qualifications on or 

Before February 28, 1992 (§ 493.1491) 

We proposed removing § 493.1491 as 

individuals can no longer qualify under 

this provision. 

We did not receive public comments 

on this provision and are finalizing the 

proposed change to remove § 493.1491. 

Individuals qualified under the previous 

§ 493.1491(b)(6) are grandfathered by 

the new provision at § 493.1489(b)(5), 

provided they have been continuously 

employed in their positions since the 

effective date of this final rule. 

17. Proposed Removal of Earned Degree 

in Physical Science as an Educational 

Requirement 

At §§ 493.1405, 493.1411, 493.1423, 

493.1443, 493.1449, 493.1461, and 

493.1489, we proposed to remove 

‘‘physical science’’ and add a new 

educational requirement for the ability 

to qualify based on SH. We concur with 

CLIAC’s recommendation that a degree 

in physical science should be removed 

from the CLIA regulations as it is too 

broad and may not include relevant 

laboratory science coursework. It is a 

broad discipline often described as the 

study of nonliving systems, such as 

astronomy, physics, and earth sciences. 

Generally, these types of degrees are not 

related to clinical laboratory testing. 

Due to variation in usage and the 

absence of universally accepted 

definitions, a ‘‘physical science degree’’ 

is difficult to define for regulatory 

purposes. We stated that we believe that 

the proposed semester algorithm will 

allow individuals to qualify in the 

absence of a traditional chemical, 

biological, or clinical laboratory science 

or medical technology degree. An 

individual graduating with a physical 

science degree may or may not have 

sufficient course experience to meet the 

educational requirement, so the degree 

alone should not be listed among those 

that satisfy the educational requirement. 

We note that in some instances, 

individuals with these types of degrees 

have been able to qualify as high 

complexity TP under § 493.1489 and 

GSs under § 493.1461(b)(2) as long as 

they have the applicable training or 

experience (see section I.D.1.c. of the 

proposed rule). 

We received public comments on 

these proposals. The following is a 

summary of the public comments we 

received and our responses. 

Comment: Many commenters agreed 

with removing physical science as a 

qualifying degree, stating that it is not 

applicable to clinical laboratory work. A 

commenter noted that it takes years to 

become proficient in performing high 

complexity testing, such as identifying 

abnormal cells in blood, body fluids, 

and tissues, and disagreed with the 

removal of physical science as a 

qualifying degree. 

Response: We agree that physical 

science coursework may not be 

applicable to clinical laboratory work, 

as discussed in the proposed rule. We 

also concur with CLIAC’s 

recommendation that a degree in 

physical science should be removed 

from the CLIA regulations as it is too 

broad and may not include relevant 

laboratory science coursework. We have 

added an algorithm that may continue 

to allow individuals with physical 

science degrees to qualify provided they 

meet the requirements specified in the 

educational algorithm. 

After consideration of the comments 

received, we are finalizing the proposed 

changes at §§ 493.1405, 493.1411, 

493.1423, 493.1443, 493.1449, 493.1461, 

and 493.1489 to remove ‘‘physical 

science.’’ 

18. Clinical Laboratory Science and 

Medical Technology 

At §§ 493.1405(b)(3) and (b)(5)(i), 

493.1411(b)(4) and (6), 493.1443(b)(3)(i), 

and 493.1449(c)(3)(i), (c)(5)(i), (d)(3)(i), 

(d)(5)(i), (h)(2)(i), and (i)(2)(i), we 

proposed to remove any text referring to 

‘‘medical technology’’ degrees and 

replace such text with references to 

degrees in ‘‘clinical laboratory science 

and medical technology’’ so that the 

latter phrase appears consistently 

throughout subpart M. Originally, 

degrees were given in medical 

technology; however, the naming 

convention for medical technology 

degrees has changed since the 

regulations were first published in the 

February 1992 final rule with comment 

period. We stated in the proposed rule 

that the degree is now referred to as 

clinical laboratory science and that a 

clinical laboratory science degree is 

synonymous with a medical technology 

degree. 

We received public comments on 

these proposals. The following is a 

summary of the public comments we 

received and our responses. 

Comment: Several commenters 

suggested the inclusion of medical 

laboratory science in addition to clinical 

laboratory science and medical 

technology throughout the personnel 

qualifications. 

Response: We agree with the 

commenters and are amending 

applicable sections of subpart M to 

include both clinical and medical 

laboratory science, as discussed 

previously. 

After consideration of the comments 

received, we are finalizing the proposed 

changes as indicated in sections III.B.1, 

3, 6, 7, 8, 10, and 11 of this final rule. 

We are also amending applicable 

sections of subpart M in this final rule 

to include medical laboratory science. 

19. Other Conforming Amendments 

In preparing this final rule, we 

identified regulatory cross-references in 

certain existing regulations that will be 

outdated as a result of our proposed and 

final changes to the subpart M 


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regulations. Accordingly, in this final 

rule we are updating the regulatory 

cross-references at §§ 493.945(b)(2), 

(b)(3)(i), (b)(3)(ii)(C) and (F), 

493.1273(b), 493.1274(c)(1), 493.1417(a), 

493.1451(c), 493.1455(a), and 

493.1469(a) to be consistent with the 

finalized regulations. Specifically, we 

are updating: 

• the regulatory cross-reference at 

§ 493.945(b)(2) from § 493.1449(k) to 

493.1449(e). 

• the regulatory cross-reference at 

§ 493.945(b)(3)(i) from § 493.1449(k) to 

493.1449(e). 

• the regulatory cross-reference at 

§ 493.945(b)(3)(ii)(C) from § 493.1449(k) 

to 493.1449(e). 

• the regulatory cross-reference at 

§ 493.945(b)(3)(ii)(F) from § 493.1449(k) 

to 493.1449(e). 

• the regulatory cross-references at 

§ 493.1273(b) from § 493.1449(l) to 

493.1449(f) and from 493.1449(m) to 

493.1449(g). 

• the regulatory cross-reference at 

§ 493.1274(c)(1)(i)(A) from § 493.1449(k) 

to 493.1449(e). 

• the regulatory cross-reference at 

§ 493.1417(a) from § 493.1405(b)(3)(i) to 

493.1405(b)(3). 

• the regulatory cross-reference at 

§ 493.1451(c) from § 493.1449(k)(2) to 

493.1449(e)(2). 

• the regulatory cross-reference at 

§ 493.1455(a) from §§ 493.1443(b)(3)(i) 

to 493.1443(b)(3) and from 

493.1443(b)(6) to 493.1443(b)(5). 

• the regulatory cross-reference at 

§ 493.1469(a) from § 493.1449(k) to 

493.1449(e). 

C. Change to CLIA Requirements for 

Alternative Sanctions for CoW 

Laboratories Under § 493.1804(c)(1) 

As discussed in section I.C. of the 

proposed rule, we proposed amending 

§ 493.1804(c)(1) by removing the phrase 

‘‘(CMS does not impose alternative 

sanctions on laboratories that have 

certificates of waiver because those 

laboratories are not inspected for 

compliance with condition-level 

requirements.)’’. 

We received public comments on 

these proposals at § 493.1804(c)(1). The 

following is a summary of the public 

comments we received and our 

responses. 

Comment: Several commenters 

supported the proposed amendment to 

allow alternative sanctions for CoW 

laboratories. 

Response: We appreciate the 

commenters’ support and are finalizing 

to remove the phrase ‘‘Except for a 

condition level deficiency under 

§ 493.41 or § 493.1100(a), CMS does not 

impose alternative sanctions on 

laboratories that have certificates of 

waiver because those laboratories are 

not routinely inspected for compliance 

with condition-level requirements.’’ As 

previously discussed, the language 

‘‘Except for a condition level deficiency 

under § 493.41 or § 493.1100(a)’’ was 

added in the Medicare and Medicaid 

Programs, Clinical Laboratory 

Improvement Amendments (CLIA), and 

Patient Protection and Affordable Care 

Act; Additional Policy and Regulatory 

Revisions in Response to the COVID–19 

Public Health Emergency interim final 

rule with comment period and was only 

effective during the PHE. Consistent 

with the finalized amendment to 

remove the current parenthetical 

§ 493.1804(c), this language will also be 

deleted as of the effective date of this 

final rule. 

After consideration of the comments 

received, we are finalizing the proposed 

amendment at § 493.1804(c)(1). 

D. Delayed Effective Date for Certain 

Regulations Revised in This Final Rule 

We recognize that time will be needed 

for laboratories, accreditation 

organizations, exempt States, and 

surveyors to implement the revised 

histocompatibility and personnel 

requirements. As such we are delaying 

the effective date of the revisions to the 

Histocompatibility (§ 493.1278) and 

Personnel (§§ 493.1359(b)(2), (c), and 

(d), 493.1405(b), 493.1406, 493.1407(c), 

493.1411(b), 493.1423(b), 493.1443(b), 

493.1445(c) and (e)(10), 493.1449, 

493.1461(c) and (d)(3)(i), 493.1461(e), 

493.1462, 493.1463(b)(4), 493.1483 

introductory text and (b), 493.1489(b), 

and 493.1491)) regulations, the other 

related conforming amendments 

(§§ 493.945(b)(2), (b)(3)(i), and 

(b)(3)(ii)(C) and (F), 493.1273(b), 

493.1274(c)(1)(i)(A), 493.1417(a), 

493.1451(c), 493.1455(a), and 

493.1469(a)), and the amendments to 

the Definitions (§ 493.2) for continuing 

education (CE) credit hours, doctoral 

degree, experience directing or 

supervising, laboratory training or 

experience, and midlevel practitioner 

until December 28, 2024. The delayed 

effective date reflects the timeframe that 

we believe the laboratories, 

accreditation organizations, exempt 

States, and surveyors will need to adopt 

and implement these revised 

regulations. 

IV. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

In the proposed rule, we solicited 

public comment on each of the section 

3506(c)(2)(A) required issues for the 

following sections of this document that 

contain information collection 

requirements (ICRs). 

A. CLIA Fees 

This portion of the final rule does not 

impose information collection 

requirements, that is, reporting, 

recordkeeping, or third-party disclosure 

requirements. Consequently, there is no 

need for review by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.). 

B. Histocompatibility, Personnel, and 

Alternative Sanctions 

1. Laboratory Costs To Update Policies 

and Procedures 

We expect that the 33,747 CoC and 

CoA laboratories would incur costs for 

the time needed to review the revised 

personnel regulations and update their 

policies and procedures to be in 

compliance. The total one-time burden 

per laboratory to review and update 

affected policies and procedures is 5 to 

7 hours (33,747 × 5 or 7). A management 

level employee (11–9111) would 

perform this task at an hourly wage of 

$57.61 per hour as published by the 

2021 Bureau of Labor Statistics.24 The 

wage rate would be $115.22 to include 

overhead and fringe benefits. The total 

cost would range from $19,441,647 to 

$27,218,305 (33,747 laboratories × 5- or 

7-hours × $115.22). 

Similarly, we expect that the 27,257 

PPM laboratories would incur costs for 

the time needed to review and update 

the one change clarifying the 

requirement for CAs in PPM 

laboratories. We assume a one-time 

burden of 0.25 to 0.5 hours per 


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laboratory for this task (27,257 × 0.25 or 

0.5 hours). A management level 

employee (11–9111) would perform this 

task at an hourly wage of $57.61 per 

hour as published by the 2021 Bureau 

of Labor Statistics.25 The wage rate 

would be $115.22 to include overhead 

and fringe benefits. The total cost would 

range from $785,138 to $1,570,276 

(27,257 laboratories × 0.25- or 0.5-hours 

× $115.22). 

The changes to the histocompatibility 

requirements affect approximately 247 

laboratories that perform testing in this 

specialty. The laboratories may need to 

make additional changes to their 

policies and procedures for the 

histocompatibility updates. We assume 

a one-time cost of 1 to 2 hours per 

laboratory for this task (247 × 1 or 2). A 

management level employee (11–9111) 

would perform this task at an hourly 

wage of $57.61 per hour as published by 

the 2021 Bureau of Labor Statistics.26

The wage rate would be $115.22 to 

include overhead and fringe benefits. 

The total cost would range from $28,459 

to $56,919 (247 laboratories × 1- or 2- 

hours × $115.22). 

Subsequent to the issuance of the July 

2022 proposed rule (87 FR 44896), we 

published a 60-day notice in the Federal 

Register (88 FR 44132) to solicit public 

comments on the information collection 

requirements contained in this section. 

The revised information collection 

request was still under development 

when the proposed rule published. 

Upon publication of this final rule, the 

revised ICR will be submitted to OMB 

under OMB control number: 0938–0612, 

which expires January 31, 2024. 

2. Accreditation Organization and 

Exempt State Costs To Update Policies 

and Procedures 

Seven approved accrediting 

organizations and two exempt States 

have to review their policies and 

procedures, provide updates and submit 

the changes to CMS for approval (9 

organizations/exempt States × 10 or 15 

hours). We assume a one-time cost of 10 

to 15 hours to identify the applicable 

legal obligations and to develop the 

policies and procedures needed to 

reflect the new requirements for 

personnel and histocompatibility. A 

management level employee (11–9111) 

would perform this task at an hourly 

wage of $57.61 per hour as published by 

the 2021 Bureau of Labor Statistics.27

The wage rate would be $115.22 to 

include overhead and fringe benefits. 

The total cost would range from $10,370 

to $15,555 (9 × 10- or 15 hours × 

$115.22). 

Subsequent to the issuance of the July 

2022 proposed rule (87 FR 44896), we 

published a 60-day notice in the Federal 

Register (88 FR 44132) to solicit public 

comments on the information collection 

requirements contained in this section. 

The revised information collection 

request was still under development 

when the proposed rule published. 

Upon publication of this final rule, the 

revised ICR will be submitted to OMB 

under OMB control number: 0938–0686, 

which expires January 31, 2024. 

Table 11 reflects the total burden and 

associated costs for the provisions 

included in this final rule. 

V. Regulatory Impact Analysis 

A. Statement of Need 

1. CLIA Fees 

As discussed in section I. of the 

proposed rule, when CLIA was enacted 

and its implementing regulations were 

finalized in 1992, CLIA fees were 

established based on estimates as to the 

average time a survey would take, cost 

of the surveyor salary per hour, as well 

as the size of the laboratory (schedules 

A, B, etc.). As discussed in section II. of 

the proposed rule, we proposed to 

increase certain CLIA fees, add new 

CLIA fees, and institute a biennial fee 

increase based on our analysis of the 

overall level of collections relative to 

the costs of maintaining the CLIA 

program, which project a shortfall 

beginning in calendar year 2025. 

2. Histocompatibility, Personnel, 

Alternative Sanctions 

This rule finalizes changes to update 

the CLIA regulations concerning 

histocompatibility (§ 493.1278), 

personnel (§§ 493.1351 through 

493.1495), and alternative sanctions for 

laboratories operating under a CoW 

(§ 493.1804). With few exceptions, no 

changes have been made to the 

requirements listed previously in this 

final rule since the CLIA regulations 

were finalized in the February 1992 

final rule with comment period (57 FR 

7002). HHS assessed the need to update 

the sections addressed in this rule as 

many changes have occurred in the 

practice of laboratory medicine since 

that time, and other parts of the 

regulations have since been updated to 

eliminate redundancies and streamline 

requirements. We based our decision to 

update the regulations and incorporate 

the changes being finalized in this rule 

in part, upon advice from CLIAC 

(www.cdc.gov/cliac/pastmeetings.html), a Federal advisory 

committee charged with providing 

recommendations to HHS on revisions 

needed to CLIA and from solicited 

public input via the 2018 RFI (83 FR 

1004). 

Because the specialty of 

histocompatibility is an evolving area of 

the clinical laboratory, several changes 

were made to update and clarify the 

histocompatibility requirements 


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TABLE 11: Summary of All Costs for Collection of Information in this Final Rule 

Burden Hours 

Information Collection Requests* Increase/Decrease(+/-)* Cost(+/-)* 

A. Laboratory Costs to Update Policies and Procedures 

CoC/CoA +7 $27,218,305 

PPM +0.5 $1,570,276 

Histocompatibility +2 $56,919 

B. Accreditation Organization and Exempt State Costs to 

Update Policies and Procedures +15 $15,555 

TOTAL +24.5 +28,861,055 

* All costs reflected in this table are one-time only costs. There are no ongoing costs. 
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90023 

finalized in the 2003 final rule (68 FR 

3640). Since then, there have continued 

to be advancements in 

histocompatibility testing. As a result, 

some requirements have become 

obsolete and may preclude using 

current, improved methods and 

practices. As already mentioned, there 

have been updates to other parts of the 

CLIA regulations to eliminate 

redundancy with general quality system 

requirements. However, changes to 

eliminate redundancy have not 

previously been made in the 

histocompatibility specialty, which we 

believe would simplify and streamline 

the regulations. Thus, we are finalizing 

the elimination of redundant 

histocompatibility specialty regulations 

in this final rule. 

Provisions to end a phase-in period, 

previously included in subpart M, that 

allowed individuals with an earned 

doctoral degree in a chemical, physical, 

biological, or clinical laboratory science 

to meet the qualification requirements 

for LDs of high complexity testing, prior 

to obtaining board certification, were 

finalized in the 2003 final rule. This 

rule also revised and expanded the 

qualifications required for such 

individuals to direct a laboratory 

performing high complexity testing. No 

other changes have been made to clarify 

or update subpart M since 1992, even 

though the top 10 laboratory 

deficiencies have historically continued 

to include qualification requirements 

and responsibilities for moderate and 

high complexity LDs (https://

www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/ 

CLIAtopten.pdf). These high numbers of 

deficiencies may be due, in part, to the 

redundancy throughout subpart M or to 

requirements that are unclear, both of 

which may be an ongoing source of 

confusion for laboratories and 

individuals seeking to determine their 

qualification status. The number of 

deficiencies may also be due to 

laboratories whose directors are on-site 

infrequently or not at all. 

The CLIA requirements at § 493.1804 

describe general considerations for the 

imposition of sanctions under the CLIA 

program. This includes principal or 

alternative sanctions described in 

§ 493.1804(c). This section specifies that 

alternative sanctions are not imposed on 

laboratories issued a CoW, but 

discretion is permitted in applying 

principal or alternative sanctions to 

laboratories issued other certificate 

types. Since the CLIA statute at 42 

U.S.C. 263a(h) does not make this 

distinction with respect to alternative 

sanctions, we found that § 493.1804(c) 

can be updated to reflect CMS’ belief 

that both alternative sanctions and 

principal sanctions should be an option 

in order to create parity for all certificate 

types. In some cases, we believe the 

imposition of principal sanctions on 

CoW laboratories is not appropriate and 

could create an undue burden on these 

laboratories for which, unlike 

laboratories with other certificate types, 

CMS cannot currently impose 

alternative sanctions, if appropriate. 

In summary, we based our decision to 

update our regulations at § 493.1278 

related to histocompatibility on changes 

in practice, advice from CLIAC, and 

responses to the 2018 RFI. We based our 

decision to update this rule for the 

personnel requirements in subpart M 

§§ 493.1351 through 493.1495 on advice 

from CLIAC, common questions we 

have received, and responses to the 

2018 RFI. This final rule clarifies this 

subpart by deleting obsolete and 

redundant regulations and specifying 

personnel qualifications and 

responsibilities. We based our decision 

to update our regulation at § 493.1804(c) 

to allow for alternative sanctions to be 

imposed on CoW laboratories on 

responses received to the 2018 RFI. 

B. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), Executive Order 14094 on 

Modernizing Regulatory Review (April 

6, 2023), the Regulatory Flexibility Act 

(RFA) (September 19, 1980, Pub. L. 96– 

354), section 1102(b) of the Social 

Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999), and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 14094 

amended section 3(f) of Executive Order 

12866 to define a ‘‘significant regulatory 

action’’ as an action that is likely to 

result in a rule: (1) having an annual 

effect on the economy of $200 million 

or more in any 1 year, or adversely 

affect in a material way the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local or Tribal governments or 

communities; (2) creating a serious 

inconsistency or otherwise interfering 

with an action taken or planned by 

another agency; (3) materially altering 

the budgetary impacts of entitlements, 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof; or (4) raising legal or policy 

issues for which centralized review 

would meaningfully further the 

President’s priorities or the principles 

set forth in this Executive Order. 

A regulatory impact analysis (RIA) 

must be prepared for major rules with 

significant regulatory actions and/or 

with significant effects as per section 

3(f)(1) of $200 million or more in any 1 

year. Based on our estimates, OMB’s 

Office of Information and Regulatory 

Affairs has determined this rulemaking 

is not significant per section 3(f)(1) as 

measured by the $200 million or more 

in any 1 year, since neither the low 

estimate of $20,894,051 nor the high 

estimate of $30,520,189 exceeds the 

$200 million annual threshold. 

The Regulatory Flexibility Act (RFA) 

requires agencies to analyze options for 

regulatory relief of small entities if a 

rule has a significant impact on a 

substantial number of small entities. For 

purposes of the RFA, we estimate that 

the great majority of clinical laboratories 

and AOs are small entities, either by 

being nonprofit organizations or by 

meeting the Small Business 

Administration definition of a small 

business (having revenues of less than 

$8.0 million to $41.5 million in any 1 

year). For purposes of the RFA, 

approximately 76 percent of clinical 

laboratories qualify as small entities 

based on their nonprofit status as 

reported in the American Hospital 

Association Fast Fact Sheet, updated 

January 2022 (https://www.aha.org/ 

statistics/fast-facts-us-hospitals), and 

100 percent of the AOs are nonprofit 

organizations as required in the CLIA 

regulations at § 493.551(a). Individuals 

and States are not included in the 

definition of a small entity. This 

percentage of small entities 

encompasses a substantial number of 

businesses and laboratories that will be 

affected by this final rule. However, we 

are unable to find relevant revenue data 

to compare the final rule’s cost on a per 

small entity basis. AOs do not all 

provide the same services, PT modules, 

or analytes. Clinical laboratories provide 

different levels of testing, including 

referring some testing to outside 

laboratories. The changes regarding LDs 

may not affect laboratories that are 

already in compliance based on their 

prior policies, while other laboratories 

that do not have LDs on site will be 

impacted at different levels based on the 


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90024 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

changes required to be in compliance 

with this final rule. The other changes 

being finalized will affect some 

laboratories more than others. Due to 

the inconsistency of the impact among 

all the laboratories and the lack of 

relevant data, we have provided a range 

of cost estimates as detailed below in 

the Anticipated Effects section (section 

C). As its measure of significant 

economic impact on a substantial 

number of small entities, HHS uses a 

change in revenue of more than 3 to 5 

percent. We do not believe that this 

threshold will be reached by the 

requirements in this final rule, and it is 

anticipated that the benefits obtained by 

ensuring quality laboratory testing will 

outweigh the costs (see Tables 12 and 

13). While a substantial number of 

clinical laboratories and AOs are 

affected by this rule, the impact is not 

economically significant. Therefore, the 

Secretary has certified that this final 

rule will not have a significant 

economic impact on a substantial 

number of small entities. We are 

voluntarily preparing a Regulatory 

Impact Analysis, including both a 

qualitative and quantitative analysis. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital located outside a 

metropolitan statistical area with fewer 

than 100 beds. There are approximately 

654 small rural hospitals in the United 

States. Such hospitals often provide 

limited laboratory services or may refer 

all their testing to larger facilities. 

Although we are unable to estimate the 

number of laboratories that support 

small rural hospitals, we do not expect 

that the rule will have a significant 

impact on small rural hospitals. 

Therefore, the Secretary has certified 

that this final rule will not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule whose mandates 

require spending in any 1 year of $100 

million in 1995 dollars, updated 

annually for inflation. In 2023, that 

threshold was approximately $177 

million. We found that this final rule 

would not impose an unfunded 

mandate on States, Tribal governments, 

and the private sector of more than $177 

million annually. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

Two States have exempt status, which 

means we have determined that the 

State has enacted laws relating to the 

laboratory requirements that are equal to 

or more stringent than CLIA 

requirements, and the State licensure 

program has been approved by us. With 

implementation of the final rule, the 

two States, New York and Washington, 

would need to update their policies and 

procedures to maintain their exempt 

status but would otherwise not incur 

additional costs. Therefore, this final 

rule would not have a substantial direct 

effect on State or local governments, 

preempt States, or otherwise have a 

Federalism implication, and there is no 

change in the distribution of power and 

responsibilities among the various 

levels of government. 

We did not receive any comments for 

the Overall Impact section in the 

proposed rule. 

C. Anticipated Effects 

Tables 12 and 13 reflect the estimated 

impact for the provisions included in 

this final rule. 

1. Fees 

The final rule impacts approximately 

298,791 CLIA certified laboratories. 

Certificate of Waiver (CoW) = 235,175; 

Certificate for Provider-performed 

Microscopy (PPM) Procedures = 29,717; 

Certificate of Registration (CoR) = 2,891; 

Certificate of Compliance (CoC) = 

17,694; Certificate of Accreditation 

(CoA) = 15,935. (Data from Casper 85s 

02/07/2022) 

a. Two-Part Biennial Survey Fees 

(1) CoC Laboratories Compliance Survey 

Fees 

Table 14 reflects the national average 

of compliance fees for each 

classification of laboratories (schedules) 


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TABLE 12: Summary of Estimated Impact for Histocompatibility and Personnel 

Regulations 

Chane:e Low estimate Hie:h estimate 

Laboratories updating policies and procedures related to $20,255,244 $28,845,500 personnel and histocompatibility 

Accrediting organizations and exempt States updating 

policies and procedures related to personnel, $10,370 $15,555 

histocompatibilitv, and laboratory director site visit 

Travel for site visits-Driving $161,719 $727,500 

Travel for site visits-Flying $466,718 $931,634 

Total Increased cost $20,894,051 $30,520,189 

TABLE 13: Summary of Estimated Impact for Fee Regulations 

Chane:e Estimate 

CLIA Fee Regulations $24,371,183 

Total Increased cost $24,371,183 
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90025 

that requires inspection. Specifically, 

Table 14 represents the national average 

for each schedule for the current 

Compliance Survey Fees (noted with a 

‘‘c’’) as paid biennially by laboratories 

that hold a CoC and the national average 

for each schedule for the new 

Compliance Survey Fees (noted with a 

‘‘n’’) that will be paid after the first 

biennial two-part fee increase of 4.9598 

percent along with an across-the-board 

increase of 18 percent by laboratories 

that hold a CoC. As discussed in section 

II. of this final rule, Table 14 shows 

estimated increases for CoC laboratories 

subject to the biennial fee increase. 

(2) CoA Laboratories Validation Survey 

Fees. 

Table 15 shows the national average 

of the Validation Survey Fee for each 

schedule of accredited laboratory. 

Specifically, Table 15 represents the 

national average fees for each schedule 

for the current Validation Survey Fee 

(noted with a ‘‘c’’) as paid biennially by 

laboratories that hold a CoA and the 

national average for the new Validation 

Survey Fee (noted with an ‘‘n’’) that will 

be paid after the first biennial two-part 

fee increase of 4.9598 percent along 

with an across-the-board increase of 18 

percent by laboratories that hold a CoA. 

As discussed in section II. of this final 

rule, Table 15 shows estimated 

increases for CoA laboratories subject to 

the biennial fee increase. 


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TABLE 14: Two-part Fee for CoC Survey Fees* 

Laboratory Current New average Number of Number of 

classification average (c) (n) Laboratories per Laboratories 

(schedules) ATBand schedule* per schedule 

Biennial divided by 2** 

Increase= 

18% *4.96% 

V $360 $446 6,794 3,397 

A $1,192 $1,477 3,853 1,926.5 

B $1,591 $1,970 143 71.5 

C $1,988 $2,463 1,945 972.5 

D $2,336 $2,894 186 93 

E $2,684 $3,325 1,521 760.5 

F $3,032 $3,755 822 411 

G $3,380 $4,187 520 260 

H $3,728 $4,618 1,771 885.5 

I $4,076 $5,049 204 102 

J $4,408 $5,459 205 102.5 

*Number ofCoC labs by laboratory classification (schedules) (Data from Certification and 

Survey Provider Enhanced Reporting (CASPER) 0086S CUA Laboratories Schedule Counts) 

Includes CoR labs of application type CoC. 

**The fees are biennial; therefore, approximately half the CoC laboratories are affected annually. 
90026 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

(3) Certificate of Waiver (CoW) Waived 

Test Categorization Certificate Fee 

Table 16 shows the additional fee to 

be added to Certificates of Waiver (CoW) 

to offset program obligations to FDA for 

its role in the categorization of tests and 

test systems as waived. Specifically, 

Table 16 represents the certificate fee 

(noted with a ‘‘c’’) as paid biennially by 

laboratories that hold a CoW and the 

new certificate Fee (noted with an ‘‘n’’) 

that will be paid by laboratories that 

hold a CoW. As discussed in section II. 

of this final rule, Table 16 reflects a total 

increase of $25 as each laboratory’s part 

of the Waived test categorization fee. 

This table also takes into account the 

first biennial two-part fee increase of 

4.9598 percent along with an across-theboard increase of 18 percent. 

(4) Two-part Biennial Certificate Fees 

Table 17 shows the national average 

of the certificate fee for each schedule 

for the CoC and CoA laboratories and 

shows the CoW, PPM, and CoR 

certificate fees. Specifically, Table 17 

represents the national average fees for 

each schedule for the CoC and CoA 

Certificate Fee and the CoW, PPM, and 

CoR (noted with a ‘‘c’’) as paid 

biennially by laboratories that hold a 

CoC, CoA, CoW, PPM, or CoR and the 

national average fees for each schedule 

for the new CoC and CoA Certificate Fee 

and the CoW, PPM, and CoR (noted 

with an ‘‘n’’) that will be paid after the 

first biennial two-part fee increase of 

4.9598 percent with an 18 percent 

across the board increase by laboratories 

that hold a CoC, CoA, CoW, PPM, or 

CoR. As discussed in section II. of this 

final rule, Table 17 reflects estimated 

increases for all laboratory types subject 

to the biennial fee increase. 


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TABLE 15: Two-part fee for Certificate of Accreditation (CoA) Validation Survey Fees* 

Laboratory Current New average Number of Number of 

classification average (c) (n) laboratories per Laboratories 

(schedules) ATBand schedule* per schedule 

Biennial divided by 2** 

Increase= 18% 

*4.96% 

V $18 $22 2,174 1,087 

A $60 $74 2,538 1,269 

B $80 $98 129 64.5 

C $99 $123 1,771 885.5 

D $117 $145 175 87.5 

E $134 $166 1,577 788.5 

F $152 $188 876 438 

G $169 $209 5802 291 

H $186 $231 3,077 1,538.5 

I $204 $252 1,123 561.5 

J $220 $273 1,913 956.5 

*Number ofCoA labs by laboratory classification (schedules) (Data from CASPER 0086S CUA 

Laboratories Schedule Counts dated 10/0 l/2019-09/30/2021) Includes CoR labs of application type 

CoA. 

**The fees are biennial; therefore, approximately half the CoA laboratories are affected annually. 

TABLE 16: Certificate of Waiver (CoW) Waived Test Categorization Fee* 

Current New Fee (n) based on $25 CoW 

Type of CLIA certificate Fee (c) increase with the ATB and Biennial 

Increase of 18% *4.96% 

Certificate of Waiver $180 $248 (CoW) 

*Total CoW lab estimate going into FY 2024 is 235, 175/2 = 117,588. The fees are biennial; 

therefore, approximately half the CoW laboratories are affected annually. 
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90027 

b. New Replacement and Revised Fees 

Table 18 shows the cost of the 

replacement and revised certificate fees 

for each certificate type. These fees have 

not been charged prior to this rule. 


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TABLE 17: Two-part Biennial Certificate Fee 

TypeofCLIA Laboratory Current New Number of Number of 

Certificate schedule fee (c) average laboratories* Laboratories 

(n) divided by 

ATB 2** 

and 

Biennial 

Increase 

=18% 

*4.96% 

Certificate of Waiver Not $180.00 $248.00 235,175 117,587.5 

(CoW) applicable * 

Certificate for Not $240.00 $297 29,717 14,858.5 

Provider-performed applicable 

Microscopy (PPM) 

Procedures 

Coe CoA Coe CoA 

Certificate of V $180.00 $223 6,794 2,174 3,397 1,087 

Compliance (CoC) 

and Certificate of 

Accreditation (CoA) 

CoC andCoA A $180.00 $223 3,853 2,538 1,926 1,269 

.5 

CoC andCoA B 180.00 $223 143 129 71.5 64.5 

Coe andCoA C $516.00 $639 1,945 1,771 972.5 885.5 

Coe andCoA D $528.00 $654 186 175 93 87.5 

CoC andCoA E $780.00 $966 1,521 1,577 760.5 788.5 

Coe andCoA F $1,320.00 $1,635 822 876 411 438 

CoC andCoA G $1,860.00 $2,304 520 582 260 291 

Coe andCoA H $2,448.00 $3,032 1,771 3,077 885.5 1,538. 

5 

CoC andCoA I $7,464.00 $9,244 204 1,123 102 561.5 

Coe andCoA J $9,528.00 $11,801 205 1,913 102.5 956.5 

Certificate of Not $150 $184 2891 1,445.5 

Registration (CoR) applicable 

*CoW $248 includes the 4.96% and 18% Increases +$25. 

**Number of laboratories from CASPER 0086S CLIA Laboratories Schedule Counts. 

***The fees are biennial; therefore, approximately half of the Co A laboratories are affected annually. 
90028 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

c. New Additional Fees 

Table 19 shows the cost of the 

additional fees added by this final rule. 

These fees are only paid by laboratories 

with substantiated complaint surveys, 

unsuccessful performance of PT, or 

follow-up surveys for the determination 

of correction of deficiencies found on an 

original survey. 

2. Histocompatibility, Personnel, 

Alternative Sanctions 

This final rule could impact all of the 

319,487 CLIA-certified laboratories 

(accessed from the CMS Quality 

Improvement Evaluation System (QIES) 

database September 2022) to some 

extent. The changes to the personnel 

requirements will impact 33,747 CoC 

and CoA laboratories, as well as 27,257 

PPM Certificate laboratories. The 

histocompatibility changes will impact 

247 CoC and CoA laboratories certified 

for this specialty; and the allowance for 

alternative sanctions could impact 

243,951 CoW laboratories only if they 

are found to be out of compliance with 

CLIA and subject to sanctions. The final 

rule will also impact the seven CLIAapproved AOs and two exempt States. 

Although complete data are not 

available to calculate all estimated costs 

and benefits that would result from the 

changes in this rule, we are providing 

an analysis of the potential impact 

based on available information and 

certain assumptions. Implementation of 

these requirements will result in 

changes that are anticipated to have 

both quantifiable and non-quantifiable 

impacts on laboratories, AOs, and 

exempt States, as specified previously 

in this final rule. In estimating the 

quantifiable impacts, we include costs 

to CoC, CoA, and PPM laboratories that 

will result from the need to update 


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TABLE 18: CLIA Replacement and Revised Certificates FY2019* 

Certificate Number of Replacement Cost of Number of Revised Cost of 

type Certificates issued in Replacement Certificates issued in Revised 

FY2019 Certificate FY2019 Certificate 

CoC 259 $75 515 $150 

cow 2,824 $75 6,985 $95 

CoA 496 $75 505 $150 

PPM 525 $75 984 $95 

Total: 4104 $75 8989 $150 

*Number of Replacement and Revised Certificates FY2019 (Data from CASPER 0104D CLIA 116 Activity 

report). 

TABLE 19: New Additional Fees 

Affected Total Hours Range of Cost Estimate for 

CLIA Number of Hourly new fees per incident 

Fees Certificate Affected Cost Occupation Low 

type(s) Laboratories Low High Estimate High Estimate 

* 

Substantiated All Laboratory $174.78 13-1041 

Complaints types 56 I 43-1011 5.00 184.75 $874 $32,291 

43-9199 

Unsuccessful Certificate of 13-1041 

Proficiency Compliance 1,308 $174.78 43-1011 1.25 32.25 $218 $5,637 (CoC) Testing (PT) laboratories 43-9199 

Certificate of 

Compliance 

Follow-up (CoC) & $174.78 13-1041 

Surveys2 Certificate of 225 2 43-1011 8.65 19.08 $1,512 $3,335 

Accreditation 43-9199 

(CoA) 

laboratories 

Total $2,604 $41,263 Estimated Cost 

*Total number of affected laboratories is based on actual numbers from FY2019; Data from CASPER reporting system. 

'$75.11 hourly rate includes $36.45 (13-1041: Compliance Officer)+ $30.47 ( 43-1011: First-Line Supervisors of Office and Administrative 

Support Workers)+ $20.47 (43-9199: Office and Administrative Support Workers, All Other). The wage rate would be doubled to $174.78 to 

include overhead and fringe benefits. Data from the Department of Labor U.S. Bureau of Labor Statistics. 

2Includes Follow-up surveys on CoC and CoA laboratories and for Addition of Specialties. 
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90029 

policies and procedures. We also 

estimate costs for travel expenses that 

laboratories may incur to meet the 

requirement to have a LD on-site at least 

once every 6 months. For quantifiable 

impacts on AOs and exempt States, we 

estimate the costs for updating their 

policies and procedures to reflect the 

new requirements for personnel and 

histocompatibility. 

a. Quantifiable Impacts 

(1) Laboratory Costs To Update Policies 

and Procedures 

We expect that the 33,747 CoC and 

CoA laboratories will incur costs for the 

time needed to review the revised 

personnel regulations and update their 

policies and procedures to be in 

compliance with them. We assume a 

one-time burden of 5 to 7 hours per 

laboratory to review and update affected 

policies and procedures, and we assume 

the person performing this task would 

be a management level employee paid 

$115.22 per hour (wages, salary and 

benefits; (www.bls.gov/oes/tables.htm)). 

Therefore, we estimate the one-time 

costs for CoC and CoA laboratories to 

update policies and procedures to 

comply with the revised personnel 

requirements will range from 

$19,441,647 to $27,218,305 (see Table 

20). 

Similarly, we expect that the 27,257 

PPM laboratories will incur costs for the 

time needed to review and update the 

one change clarifying the requirement 

for CAs in PPM laboratories. We assume 

a one-time burden of 0.25 to 0.5 hours 

per laboratory for this task, also to be 

performed by a management level 

employee paid $115.22 per hour (wages, 

salary and benefits). Therefore, we 

estimate the one-time costs for PPM 

laboratories to update the single revised 

policy and procedure to comply with 

the personnel requirements will range 

from $785,138 to $1,570,276 (see Table 

20). 

The changes to the histocompatibility 

requirements when this rule is 

implemented will affect approximately 

247 laboratories that perform testing in 

this specialty (QIES database December 

16, 2022). While these laboratories are 

included in the calculations discussed 

previously in this final rule, they may 

need to make additional changes to their 

policies and procedures for the 

histocompatibility updates. We assume 

a one-time burden of one to two hours 

per laboratory for this task, as described 

previously in this final rule. Therefore, 

the laboratory costs for updating 

policies and procedures related to 

histocompatibility will range from 

$28,459 to $56,919 (see Table 20). 

(2) Accreditation Organization and 

Exempt State Costs To Update Policies 

and Procedures 

As a result of this final rule, seven 

approved accrediting organizations and 

two exempt States will have to review 

their policies and procedures, provide 

updates and submit the changes to us 

for approval. We estimate a one-time 

burden of 10 to 15 hours to identify the 

applicable legal obligations and to 

develop the policies and procedures 

needed to reflect the new requirements 

for personnel and histocompatibility. 

We assume the person performing this 

review will be a management level 

employee paid $115.22 per hour (wages, 

salary and benefits). Therefore, we 

estimate the costs for accrediting 

organizations and exempt States to 

update their policies and procedures 

will range from $10,370 to $15,555 (see 

Table 20). 

(3) Laboratory Costs for On-Site 

Laboratory Director Requirement 

Estimating the potential travel costs 

for LDs to meet the on-site requirement 

is complex, due to wide variation in the 

numbers of individuals who might incur 

travel costs, variation in the distances 

traveled and modes of transportation 

used, and variation among already 

existing State and accreditation 

requirements for LDs to be on-site at 

some frequency. In addition, we had 

limited available data on which to base 

our assumptions. Therefore, we used a 

conservative approach in calculating 

our estimates and believe the estimates 

described below may be higher than 

actual costs that will be incurred. 

In general, 10 States, one territory, 

and three out of seven AOs currently 

have some requirement for on-site visits 

by LDs, although the required 

frequencies vary. Ten States, including 

the exempt State of New York, plus the 

territory of Puerto Rico currently have 

requirements that are as stringent or 

more stringent than the provision that 

requires a LD to be on-site at least once 

every 6 months. Therefore, we have not 

counted CoC laboratories in these 10 

States or in Puerto Rico among those 

that would be impacted by the 


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TABLE 20: Estimated Costs to Update Policies and Procedures 

Total Range of Cost Estimate for 

Regulation Affected Group Number of Hourly Hours Personnel and Histocompatibility 

Change Affected Cost Changes 

Groups Low High Low Estimate High Estimate 

Personnel CoC&CoA 33,747 $115.22 5 7 $19,441,647 $27,218,305 Laboratories 

PPM 27,257 $115.22 0.25 0.50 $785,138 $1,570,276 Laboratories 

Histocompatibility CoC&CoA 247 $115.22 1 2 $28,459 $56,919 Laboratories 

Accrediting 

Personnel, Organizations 9 $115.22 10 15 $10,370 $15,555 Histocompatibility and Exempt 

States 

Total Increased Cost $20,265,614 $28,861,055 
90030 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

requirement for on-site LD visits. One 

accrediting organization American 

Association of Blood and Biotherapies 

(AABB) now requires on-site LD visits at 

least once a quarter. However, AABB 

only accredits 226 laboratories, or 

approximately 1.5 percent, of all 

accredited laboratories (QIES database, 

September 2022). Some of these 

laboratories are part of a hospital or 

other health care system that has 

laboratory specialties accredited for 

CLIA purposes by one or more of the 

other accrediting organizations, and 

therefore, will be impacted by the 

requirement for on-site LD visits. Since 

we do not have data to determine the 

number of such laboratories that are 

only accredited by AABB and already 

are meeting this requirement, and the 

number is likely to be relatively small, 

we are not adjusting the number of 

impacted laboratories based on AABB 

accreditation. 

In the 40 States, four territories, and 

the District of Columbia, where the LD 

is not required to be on-site at least 

twice per year, 25,867 CoC and CoA 

laboratories (QIES, December 16, 2022) 

may not currently meet this requirement 

and may incur travel costs to comply 

with it. We have not adjusted this 

number where the provision was 

partially met, since no frequency was 

specified for CoC laboratories in three 

additional States, CoA laboratories 

under two additional accrediting 

organizations, or laboratories in the 

exempt State of Washington. 

We assume that in most instances, the 

LD is on-site daily or more frequently 

than twice per year. Based on a review 

of State and AO information, discussed 

earlier in the preamble for this rule, we 

assume that between 5 percent (1,293) 

and 20 percent (5,173) of the CoC and 

CoA laboratories would need their LDs 

to travel twice a year to meet this 

requirement. For our estimate, we 

assumed this travel would include a 

combination of two modes of 

transportation, driving and flying. For 

the low estimate, we assumed that 1 

percent of the 25,867 laboratories, or 

259, would compensate their directors 

for flights while 4 percent, or 1,035 

laboratories, would compensate them 

for their mileage to drive. For the high 

estimate, we assumed that, at most, 2 

percent of the 25,867 laboratories, or 

517, would compensate their LD for 

flying and that 18 percent, or 4,656 

laboratories, would compensate for 

driving. 

• Driving: We believe most LDs

would drive fewer than 250 miles round 

trip to reach the laboratories they direct. 

We assume these LDs would drive to the 

location, conduct business, and return 

home the same day. We base our 

calculations for driving on the 

maximum estimated distance of 250 

miles at $0.625 cents per mile 

(government travel reimbursement rates 

for mileage (https://www.gsa.gov/travelresources)) for a maximum cost of 

$156.25 per trip. This may be an overestimate since we believe not all the 

individuals who drive would travel 250 

miles round trip. Based on the low 

estimate of 1,035 laboratories incurring 

costs for driving and our high estimate 

of 4,656 laboratories incurring costs for 

driving, our calculated cost for driving 

is estimated to range from $161,719 to 

$727,500 (see Table 21). 

• Flying: Our estimates for the cost of

flying assume that in these cases, travel 

to a remote site will be necessary. We 

believe basing it on travel to a remote 

site will over-estimate the cost since in 

many locations, although the LD may fly 

to reach their destination, they would 

not travel to remote locations and the 

travel costs would be less. However, we 

do not know the specific circumstances 

for which flying would be required. We 

estimated the maximum airfare for this 

travel to be $1500 and lodging costs to 

average $151.00 per night (based on the 

average of 100 hotel rates throughout 

the U.S. for 2020) (https://ik.imgkit.net/ 

3vlqs5axxjf/BTN/uploadedfiles/9_

Microsites/Corporate_Travel_Index/ 

CTI_2021/US_Diem/3-4_

USHotelDetail.pdf). We assumed 

lodging for two nights would be needed. 

Therefore, the total estimated cost for 

one trip would be $1,500 flight + 

$302.00 lodging or $1,802.00 per trip. 

Based on the low estimate of 259 

laboratories incurring costs for remote 

travel and our high estimate of 517 

laboratories incurring costs for remote 

travel, the range for laboratory costs for 

flying to on-site visits would be between 

$466,718 and $931,634 (see Table 21). 

Based on these assumptions for both 

driving and flying, we estimate the total 

cost for laboratories to compensate 

travel for the LD ranges from $628,437 

to $1,659,134. 


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TABLE 21: Estimated Travel Costs to Meet On-site Laboratory Director Requirement 

Airfare Hotel Driving Cost Total Impact for 

Regulation Affected Total Number of Cost Cost ($0.625/mile*250 Personnel and 

Change Group Affected Group ($151/2 Histocompatibility ($1,500) ni!?hts) miles) Re2ulation Chan2es 

CoAand Low High Low High Coe On-Site Laboratories Estimate Estimate estimate estimate 

Laboratory 1,035 4,656 Director Driving (4%) (18%) NA NA $156.25 $161,719 $727,500 

Flyin2 259 (1%) 517(2%) $1,500 $302 NIA $466,718 $931,634 

Total Increased Cost $628,437 $1,659,134 
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90031 

We did not receive any public 

comments on the discussion of the 

Anticipated Effects, Quantifiable 

Impacts, section in the proposed rule. 

b. Results 

We estimate that the overall impact of 

adding requirements for the changes in 

personnel, histocompatibility, and 

travel for LD on-site visits would range 

from $20,894,051 to $30,520,189 in the 

first year (see Table 22). 

For each of the changes, Table 23 

shows the projected range of cost 

estimates on an annual basis for 5 years 

starting in 2023. We assume costs for 

updating policies and procedures will 

be one-time costs that are only incurred 

in 2023. We assume the travel costs will 

be ongoing and will not change 

significantly over the 5-year period. The 

maximum cost estimate of 

approximately $30.5 million for the first 

year based on 2023 costs and 

approximately $1.7 million for 

subsequent years is not considered a 

significant economic impact. This final 

rule does not reach the economic 

threshold and thus is not considered a 

major rule. 


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TABLE 22: Estimated Impact for Histocompatibility and Personnel Regulations 

Change Low estimate High estimate 

Laboratories updating policies and procedures related to personnel $20,255,244 and histocompatibility* 

Accrediting organizations and exempt States updating policies and 

procedures related to personnel, histocompatibility, and laboratory $10,370 

director site visit 

Travel for site visits-Driving $161,719 

Travel for site visits-Flying $466,718 

Total Increased cost $20,894,051 

* Low/high estimates represent the sum of estimates in Table 20 to update policies and Table 21 to estimate travel 

costs. 

$28,845,500 

$15,555 

$727,500 

$931,634 

$30,520,189 

ER28DE23.022</GPH>khammond on DSKJM1Z7X2PROD with RULES3

TABLE 23: Five-Year Projection for Total Estimated Annual Costs for Personnel R

Change 2023 2024 2025 2026 

Low Hi2h Low Hi2h Low Hi2h Low Hi2h 

Policies and 

procedures- $20,255,244 $28,845,500 $0 $0 $0 $0 $0 $0 

Laboratories* 

Policies and 

proceduresAccrediting $10,370 $15,555 $0 $0 $0 $0 $0 $0 

organizations 

and Exempt 

States 

Travel-Driving $161,719 $727,500 $161,719 $727,500 $161,719 $727,500 $161,719 $727,500 

Travel-Flying $466,718 $931,634 $466,718 $931,634 $466,718 $931,634 $466,718 $931,634 

Total $20,894,051 $30,520,189 $628,437 1,659,134 $628,437 1,659,134 $628,437 1,659,134 

Increased cost 

* Low/high estimates represent the sum of estimates in Table 20 to update policies and Table 21 to estimate travel costs. 
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90033 

We did not receive any comments for 

the Anticipated Effects, Result, section 

in the proposed rule. 

c. Non-quantifiable Impacts and Benefit 

(1) CLIA Fees 

We stated in the proposed rule that 

CMS has limited knowledge of the nonquantifiable impacts and benefits and 

requested public comment on this topic. 

We note that we did not receive any 

comments for the Anticipated Effects, 

Non-quantifiable Impacts and Benefit, 

CLIA Fees section in the proposed rule. 

(2) Histocompatibility, Personnel, 

Alternative Sanctions 

With implementation of this final rule 

for histocompatibility, personnel, and 

alternative sanctions several nonquantifiable impacts, most of which are 

considered benefits, will result for 

laboratories, accrediting organizations, 

and exempt States concerning changes 

in the requirements for personnel, 

histocompatibility, and alternative 

sanctions for CoW laboratories. 

Many personnel changes in this rule 

will decrease the burden and provide 

greater flexibility for laboratories by 

increasing the number of eligible 

candidates for some personnel 

categories by expanding and clarifying 

the qualifying degrees. Examples of the 

provisions that will increase the number 

of qualified candidates for personnel 

categories include the addition of: 

clinical nurse specialists and certified 

registered nurse anesthetists in the 

definition of midlevel practitioners, a 

bachelor’s degree in respiratory therapy 

as a possible qualifying degree as a TC 

and TP for moderate and high 

complexity blood gas testing, and an 

associate or bachelor of nursing degree 

as a qualifying degree for moderate 

complexity TP. Adding these options as 

qualifying degrees does not preclude the 

need for individuals to meet clinical 

laboratory training and experience 

requirements. 

This rule will decrease burden, 

increase flexibility for laboratories, and 

streamline regulations by aligning the 

technical supervisor qualifications for 

laboratories performing 

immunohematology with those of other 

specialties such as hematology. Instead 

of limiting those qualified to serve as a 

technical supervisor in 

immunohematology to individuals with 

a doctor of medicine or doctor of 

osteopathy degree and appropriate 

certification and experience, individuals 

may also qualify with a doctoral, 

master’s, or bachelor’s degree in a 

chemical, biological, or clinical 

laboratory science or medical 

technology, or medical laboratory 

science and 1, 2, or 4 years applicable 

experience, respectively. These changes 

streamline the regulations and could 

increase a laboratory’s ability to find 

qualified personnel, especially in rural 

areas. As it is not possible to predict the 

pathway a laboratory will use to qualify 

individuals when hiring personnel, we 

cannot quantify the impacts that would 

result with this rule. 

Several other changes in this rule will 

impact laboratories and their personnel. 

However, we do not have data to 

quantify the impact. The qualification 

requirement for completing 20 CE credit 

hours, to cover LD responsibilities as 

defined in the regulations, prior to 

serving as an LD will apply to LDs for 

both moderate and high complexity 

testing except for those doctors of 

medicine, osteopathy, or podiatry who 

are certified by the American Board of 

Pathology, the American Osteopathic 

Board of Pathology, or other boards 

approved by HHS. Although there will 

be costs associated with obtaining these 

credits, currently employed LDs, at the 

effective date of the final rule, will not 

be required to obtain the 20 CE credit 

hours to retain their employment status. 

In the future, only one of several 

qualification routes for LDs will require 

the 20 CE credit hours. Accordingly, we 

cannot predict the number of 

laboratories that will choose to hire a LD 

through this qualification route. The 

impact of removing physical science 

degrees as qualifying degrees for any 

personnel categories is lessened because 

these individuals may still qualify if 

they have the required coursework and 

experience. In addition, laboratory 

personnel employed in their position on 

the effective date of the final rule, will 

continue to qualify under the applicable 

grandfather provision as long as they 

remain continuously employed in their 

positions. 

The changes to the histocompatibility 

requirements in this rule will impact 

laboratories, accrediting organizations, 

and exempt States. It will streamline the 

histocompatibility requirements and 

remove those that are no longer relevant 

based on current testing practices, 

adding flexibility for laboratories and 

removing perceived barriers to current 

practices. It will remove specific, 

redundant requirements and replace 

them with those covered in general 

under §§ 493.1251, 493.1252, 493.1256, 

and 493.1445. This will simplify the 

requirements related to procedure 

manuals; test systems, equipment, 

instruments, reagents, materials, and 

supplies; control procedures; and LD 

responsibilities. We believe these 

impacts will decrease the burden and 

positively affect laboratories certified to 

perform testing in this specialty, as well 

as health care providers and patients. 

Last, concerning the alternative 

sanctions provision, the final rule will 

allow us discretion in imposing 

alternative sanctions (that is, civil 

money penalties (CMP), directed plan of 

correction, directed portion of a plan of 

correction, and on-site State 

monitoring), rather than only being able 

to impose principal sanctions (that is, 

revocation, suspension, limitation of the 

CLIA certificate), in CoW laboratories, if 

appropriate. We believe this will 

increase flexibility, decrease potential 

burden while moving those laboratories 

toward compliance, and have no added 

economic impact on CoW laboratories. 

As previously described, this regulatory 

change could decrease the burden for 

sanctions imposed for improper 

proficiency testing referral. Although we 

have no data indicating that principal 

sanctions have been imposed on CoW 

laboratories for this reason in the past, 

if it occurred in the future, the ability to 

impose alternative sanctions, if 

appropriate, would be less punitive and 

potentially decrease any quantifiable 

economic impact. At this time, we 

cannot quantify what that impact would 

be. 

We did not receive any comments for 

the Anticipated Effects, Nonquantifiable Impacts and Benefit, 

Histocompatibility, Personnel, 

Alternative Sanctions, section in the 

proposed rule. 

D. Alternatives Considered 

1. CLIA Fees 

We considered multiple options prior 

to the proposed rule, including limiting 

across-the- board increase to varying 

percentages and timeframes required to 

achieve reasonable carryover targets for 

the CLIA program as a whole. We 

discussed multiple options in the 

December 31, 2018 notice with 

comment period (NC), including 

limiting the increase to varying 

percentages and timeframes across a 

single fee type, specifically Compliance 

Fees. When preparing the July 2022 

proposed rule, we reviewed the 

alternatives in the NC to see if they were 

viable moving forward. The approach 

proposed was the best scenario for 

longevity for maintaining the fiscal 

solvency of the user-funded CLIA 

program. We have determined that 2 

quarters worth of obligations were a 

reasonable carryover target based on 

program funding requirements and the 

time to accumulate and make available 

current year fee collections. We have 

also decided to build up to the carryover 


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90034 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

28 83 FR 67723, December 31, 2018 (https://

www.govinfo.gov/content/pkg/FR-2018-12-31/pdf/ 

2018-28359.pdf). 

target over a 3-year period to avoid 

either overcharging or undercharging. 

For example, we considered the 

following options: 

• Setting various one-time dollar 

level fee increases for CoW laboratories. 

• Setting various percentage increases 

for the one-time across-the-board 

increase. 

Public comments received from the 

December 31, 2018 notice (83 FR 67723) 

with comment period (Medicare 

Program; Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) Fees) 28 and 2022 proposed rule 

were considered during rulemaking. 

We did not receive any comments for 

the Alternatives Considered, CLIA Fee 

section in the proposed rule. 

2. Histocompatibility, Personnel, 

Alternative Sanctions 

Several alternatives were considered 

in developing these changes to the 

histocompatibility, personnel, and 

alternative sanctions requirements 

under CLIA. In all cases, one option 

would be to leave the regulations as 

written. However, because many of the 

changes being finalized for 

histocompatibility and personnel 

resulted from public input via the 2018 

RFI and recommendations made by 

CLIAC and will add flexibility, remove 

redundant or obsolete requirements, 

clarify and streamline the regulations, 

and decrease burden while maintaining 

laboratory quality, making these 

changes would be preferable. Also, the 

requirement to allow alternative 

sanctions to be imposed on CoW 

laboratories aligns the regulations with 

the CLIA statute; therefore, no other 

options were considered. 

Regarding the histocompatibility 

requirements, we initially considered 

only removing the crossmatch 

regulatory requirement at 

§ 493.1278(f)(2) which was perceived as 

a barrier to current practice with kidney 

transplantation. However, we decided to 

obtain input from interested parties to 

identify any concerns regarding 

crossmatching and other current 

regulatory requirement under the 

histocompatibility specialty. Our 

purpose for seeking input from 

interested parties through CLIAC and 

the 2018 RFI was to obtain information 

on whether the current 

histocompatibility requirements, 

including requirements for 

crossmatching, needed to be revised 

from when CLIA regulations were 

published in 1998 and 2003 to reflect 

the current practice. Our revision in this 

final rule reflects our attempt to address 

the input from interested parties and are 

intended to reflect the current practices 

as provided to CMS by interested parties 

through the 2018 RFI and CLIAC. 

One of the personnel requirements in 

this rule is to require that LDs of 

moderate and high complexity testing, 

who are qualified through an 

educational pathway other than being a 

certified anatomic or clinical 

pathologist, have at least 20 CE credit 

hours related to their LD 

responsibilities. We considered 

requiring this of all LDs. However, since 

pathologists obtain this education as 

part of their education and training, it 

would be redundant and could increase 

costs to require this, although we do not 

have data to estimate what those costs 

would be since we do not know how 

many LDs would qualify using this 

pathway. We believe it is appropriate to 

finalize this requirement for other LD 

qualification routes. This information is 

critical for fulfilling LD responsibilities 

and is not always included in education 

and training for alternative qualification 

pathways. 

Another LD requirement in this final 

rule is on-site visits to the laboratory at 

least once every 6 months, with at least 

a 4-month interval between on-site 

visits. We considered requiring these 

visits at a different frequency or not 

adding this requirement. However, 

surveyors reported that laboratories in 

which the director is not on-site tend to 

have more issues and citations when 

inspected, and 10 States, the territory of 

Puerto Rico, and one of the CLIAapproved AOs already require LD to be 

on-site at least once every 6 months. As 

a result, CLIAC recommended that LDs 

make and document at least two 

reasonably spaced on-site visits per year 

to supplement other interactions with 

staff and verify that the laboratory 

complies with laws and regulations. We 

agree with the CLIAC recommendation 

that two on-site visits per year is an 

appropriate frequency to achieve the 

intended improvement in laboratory 

compliance without adding a significant 

burden to laboratories. We will monitor 

this impact once the rule is finalized. 

Requiring these visits at a greater 

frequency and keeping all other factors 

the same would increase total projected 

costs per year. While requiring on-site 

visits only once per year would reduce 

estimated costs, it could delay the 

potential time it takes to identify 

laboratory issues that could ultimately 

result in patient harm. A third 

personnel requirement in this rule for 

which we considered various options is 

the expansion of the definition of 

midlevel practitioners to include 

certified registered anesthetists, and 

clinical nurse specialists as personnel 

qualified to serve as a LD or TP in PPM 

laboratories. Currently, this definition is 

limited to nurse midwives, nurse 

practitioners, or physician assistants, 

licensed by the State where the 

individual practices, if required in the 

State where the laboratory is located. 

We considered not expanding this 

definition or expanding it to include 

only one of the categories. However, 

certified registered anesthetists and 

clinical nurse specialists are both 

considered advanced practice registered 

nurses, as are certified nurse midwives 

and nurse practitioners. All four 

categories require at least a master’s 

degree in nursing, and all may play a 

role in providing primary and 

preventive care services to the public. 

This may include performing the 

microscopic examinations required 

under PPM. As there is no expected 

cost-increasing impact of adding either 

of these nursing categories to the 

midlevel practitioner definition, and the 

change will increase flexibility and 

access to PPM testing, we are including 

it in the final rule. 

We did not receive any comments for 

the Alternatives Considered, the 

Histocompatibility, Personnel, 

Alternative Sanctions section in the 

proposed rule. 

E. Conclusion 

1. CLIA Fees 

Although the effect of the changes 

will increase laboratory costs, 

implementation of these changes would 

be negligible in terms of workload for 

laboratories as these fee increases are 

operational and technical in nature and 

do not require additional time to be 

spent by laboratory employees. 

2. Histocompatibility, Personnel, 

Alternative Sanctions 

We estimate that the cost to 

laboratories, accrediting organizations, 

and exempt States to comply with the 

changes in the final rule would range 

between $20,894,051 and $30,520,189 

in 2023 dollars for the first year and 

between $628,437 and $1,659,134 in 

subsequent years. Although the 

requirements will increase laboratory 

costs, the implementation of the final 

rule will streamline and simplify 

regulations, add flexibility in laboratory 

hiring practices, ensure that the LD is 

on-site at least twice per year, and align 

histocompatibility testing with current 

methods and practices. This final rule 

will also allow alternative sanctions to 

be imposed on CoW laboratories. 


khammond on DSKJM1Z7X2PROD with RULES3
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90035 

We have determined that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities or a significant impact in the 

operations of a substantial number of 

small rural hospitals. For these reasons, 

we are not preparing analyses for either 

the RFA or section 1102(b) of the Act. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

Chiquita Brooks-LaSure, 

Administrator of the Centers for 

Medicare & Medicaid Services, 

approved this document on November 

11, 2023. 

Mandy K. Cohen, MD, MPH, Director 

of the Centers for Disease Control and 

Prevention, approved this document on 

November 11, 2023. 

List of Subjects in 42 CFR Part 493 

Administrative practice and 

procedure, Grant programs-health, 

Health facilities, Laboratories, Medicaid, 

Medicare, Penalties, Reporting and 

recordkeeping requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR part 

493 as set forth below: 

PART 493—LABORATORY 

REQUIREMENTS 

■ 1. Effective January 27, 2024, the 

authority citation for part 493 is revised 

to read as follows: 

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 

1395x(s)(3) and (s)(17). 

■ 2. Effective January 27, 2024, amend 

§ 493.2 by adding definitions for 

‘‘Replacement certificate’’ and ‘‘Revised 

certificate’’ in alphabetical order to read 

as follows: 

§ 493.2 Definitions. 

* * * * * 

Replacement certificate means an 

active CLIA certificate that is reissued 

with no changes made. 

* * * * * 

Revised certificate means an active 

CLIA certificate that is reissued with 

changes to one or more fields displayed 

on the certificate, such as the 

laboratory’s name, address, laboratory 

director, or approved specialties/ 

subspecialties. For purposes of this part, 

revised certificates do not include the 

issuance, renewal, change in certificate 

type, or reinstatement of a terminated 

certificate with a gap in service. 

* * * * * 

■ 3. Effective December 28, 2024, 

further amend § 493.2 by: 

■ a. Adding definitions for ‘‘Continuing 

education (CE) credit hours’’, ‘‘Doctoral 

degree’’, ‘‘Experience directing or 

supervising’’, and ‘‘Laboratory training 

or experience’’ in alphabetical order; 

and 

■ b. Revising the definition of ‘‘Midlevel 

practitioner’’. 

The additions and revision read as 

follows: 

§ 493.2 Definitions. 

* * * * * 

Continuing education (CE) credit 

hours means either continuing medical 

education (CME) or continuing 

education units (CEUs). The CE credit 

hours must cover the applicable 

laboratory director responsibilities and 

be obtained prior to qualifying as a 

laboratory director. 

* * * * * 

Doctoral degree means an earned 

post-baccalaureate degree with at least 3 

years of graduate level study that 

includes research related to clinical 

laboratory testing or advanced study in 

clinical laboratory science, medical 

laboratory science, or medical 

technology. For purposes of this part, 

doctoral degrees do not include doctors 

of medicine (MD), doctors of osteopathy 

(DO), doctors of podiatric medicine 

(DPM), doctors of veterinary medicine 

(DVM) degrees, or honorary degrees. 

* * * * * 

Experience directing or supervising 

means that the director or supervisory 

experience must be obtained in a facility 

that meets the definition of a laboratory 

under this section and is not excepted 

under § 493.3(b). 

* * * * * 

Laboratory training or experience 

means that the training or experience 

must be obtained in a facility that meets 

the definition of a laboratory under this 

section and is not excepted under 

§ 493.3(b). 

Midlevel practitioner means a nurse 

midwife, nurse practitioner, nurse 

anesthetist, clinical nurse specialist, or 

physician assistant licensed by the State 

within which the individual practices, if 

such licensing is required in the State in 

which the laboratory is located. 

* * * * * 

§ 493.557 [Amended] 

■ 4. Effective January 27, 2024, amend 

§ 493.557 in paragraph (b)(4) by 

removing the reference ‘‘§§ 493.645(a) 

and 493.646(b)’’ and adding in its place 

the reference ‘‘§§ 493.649(a) and 

493.655(b)’’. 

§ 493.575 [Amended] 

■ 5. Effective January 27, 2024, amend 

§ 493.575 in paragraph (i) by removing 

the reference ‘‘§§ 493.645(a) and 

493.646(b)’’ and adding in its place the 

reference ‘‘§§ 493.649(a) and 

493.655(b)’’. 

■ 6. Effective January 27, 2024, 

§ 493.638 is revised to read as follows: 

§ 493.638 Certificate fees. 

(a) Basic rule. Laboratories must pay 

a fee that covers the costs incurred for 

the issuance, renewal, change in 

certificate type, or reinstatement of a 

terminated certificate with a gap in 

service, and other direct administrative 

costs, as applicable. The total of fees 

collected by HHS under the laboratory 

program must be sufficient to cover the 

general costs of administering the 

laboratory certification program under 

section 353 of the PHS Act. 

(1) For registration certificates, the fee 

is a flat fee that includes the costs for 

issuing the certificates, collecting the 

fees, and evaluating whether the 

procedures, tests, or examinations listed 

on the application fall within the testing 

allowed for the requested certificate. 

(2) For a certificate of waiver, the fee 

includes the costs for issuing the 

certificate; collecting the fees; 

evaluating whether the procedures, 

tests, or examinations listed on the 

application fall within the testing 

appropriate for the requested certificate; 

and determining whether a laboratory 

test meets the criteria for a waived test. 

(3) For a certificate for PPM 

procedures, the fee includes the costs 

for issuing the certificate, collecting the 

fees; and evaluating whether the 

procedures, tests, or examinations listed 

on the application meet the criteria for 

inclusion in the subcategory of PPM 

procedures. 

(4) For a certificate of accreditation, 

the fee includes the costs for issuing the 

certificate, collecting the fees, 

evaluating the programs of accrediting 

bodies, and evaluating whether the 

procedures, tests, or examinations listed 

on the application fall within the testing 

appropriate for the requested certificate. 

(5) For a certificate of compliance, the 

fee includes the costs for issuing the 

certificates, collecting the fees, 

evaluating and monitoring proficiency 

testing programs, and evaluating 

whether the procedures, tests or 

examinations listed on the application 

fall within the testing appropriate for 

the requested certificate. 

(b) Fee amount. (1) The certificate fee 

amount is set biennially by HHS. CMS 

will publish a notice in the Federal 

Register biennially with any 

adjustments to the fee amounts, 

including any adjustments due to 

inflation, in accordance with § 493.680. 

For certificates of waiver and certificates 


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of PPM, the certificate fee amount is 

based on the category of test complexity 

performed by the laboratory. For all 

other certificate types, the fee amount is 

based on the category of test complexity 

performed by the laboratory and 

schedules or ranges of annual laboratory 

test volume (excluding waived tests and 

tests performed for quality control, 

quality assurance, or proficiency testing 

purposes) and specialties tested, with 

the amounts of the fees in each schedule 

being a function of the costs for all 

aspects of general administration of 

CLIA as set forth in paragraph (c) of this 

section. 

(2) Certificate fees are assessed and 

payable at least biennially. 

(3) The amount of the fee payable by 

the laboratory is the amount listed in 

the most recent notice published in the 

Federal Register at the time the 

application, renewal, change in 

certificate type, or reinstatement is 

processed by HHS or its designee. 

(4) After processing an application for 

an issuance, renewal, change in 

certificate type, or reinstatement of a 

terminated certificate with a gap in 

service, HHS or its designee notifies the 

laboratory of the applicable fee amount. 

(c) Classification of laboratories for 

purposes of determining the fee amount 

for certificate types other than 

certificates of waiver or certificates of 

PPM. (1) For purposes of determining a 

laboratory’s classification under this 

section, a test is a procedure or 

examination for a single analyte. (Tests 

performed for quality control, quality 

assessment, and proficiency testing are 

excluded from the laboratory’s total 

annual volume.) Each profile (that is, 

group of tests) is counted as the number 

of separate procedures or examinations; 

for example, a chemistry profile 

consisting of 18 tests is counted as 18 

separate procedures or tests. 

(2) For purposes of determining a 

laboratory’s classification under this 

section, the specialties and 

subspecialties of service for inclusion 

are: 

(i) The specialty of Microbiology, 

which includes one or more of the 

following subspecialties: 

(A) Bacteriology. 

(B) Mycobacteriology. 

(C) Mycology. 

(D) Parasitology. 

(E) Virology. 

(ii) The specialty of Serology, which 

includes one or more of the following 

subspecialties: 

(A) Syphilis Serology. 

(B) General immunology. 

(iii) The specialty of Chemistry, 

which includes one or more of the 

following subspecialties: 

(A) Routine chemistry. 

(B) Endocrinology. 

(C) Toxicology. 

(D) Urinalysis. 

(iv) The specialty of Hematology. 

(v) The specialty of 

Immunohematology, which includes 

one or more of the following 

subspecialties: 

(A) ABO grouping and Rh typing. 

(B) Unexpected antibody detection. 

(C) Compatibility testing. 

(D) Unexpected antibody 

identification. 

(vi) The specialty of Pathology, which 

includes the following subspecialties: 

(A) Cytology. 

(B) Histopathology. 

(C) Oral pathology. 

(vii) The specialty of Radiobioassay. 

(viii) The specialty of 

Histocompatibility. 

(ix) The specialty of Clinical 

Cytogenetics. 

(3) There are 11 schedules of 

laboratories for the purpose of 

determining the fee amount a laboratory 

is assessed. Each laboratory is placed 

into one of the 11 schedules in 

paragraphs (c)(3)(i) through (xi) of this 

section based on the laboratory’s scope 

and volume of testing: 

(i) Schedule V. The laboratory 

performs not more than 2,000 laboratory 

tests annually. 

(ii) Schedule A. The laboratory 

performs tests in no more than three 

specialties of service with a total annual 

volume of more than 2,000 but not more 

than 10,000 laboratory tests. 

(iii) Schedule B. The laboratory 

performs tests in at least four specialties 

of service with a total annual volume of 

not more than 10,000 laboratory tests. 

(iv) Schedule C. The laboratory 

performs tests in no more three 

specialties of service with a total annual 

volume of more than 10,000 but not 

more than 25,000 laboratory tests. 

(v) Schedule D. The laboratory 

performs tests in at least four specialties 

with a total annual volume of more than 

10,000 but not more than 25,000 

laboratory tests. 

(vi) Schedule E. The laboratory 

performs more than 25,000 but not more 

than 50,000 laboratory tests annually. 

(vii) Schedule F. The laboratory 

performs more than 50,000 but not more 

than 75,000 laboratory tests annually. 

(viii) Schedule G. The laboratory 

performs more than 75,000 but not more 

than 100,000 laboratory tests annually. 

(ix) Schedule H. The laboratory 

performs more than 100,000 but not 

more than 500,000 laboratory tests 

annually. 

(x) Schedule I. The laboratory 

performs more than 500,000 but not 

more than 1,000,000 laboratory tests 

annually. 

(xi) Schedule J. The laboratory 

performs more than 1,000,000 

laboratory tests annually. 

■ 7. Effective January 27, 2024, 

§ 493.639 is revised to read as follows: 

§ 493.639 Fees for revised and 

replacement certificates. 

(a) If, after a laboratory is issued a 

certificate, it requests a revised 

certificate, the laboratory must pay a fee 

to cover the cost of issuing a revised 

certificate. The fee for a revised 

certificate is based on the cost to issue 

the revised certificate to the laboratory. 

The fee must be paid in full before the 

revised certificate will be issued. 

(1) If laboratory services are added to 

a certificate of compliance, the 

laboratory must pay an additional fee if 

required under § 493.643(d)(2). 

(2) [Reserved] 

(b) If, after a laboratory is issued a 

certificate, it requests a replacement 

certificate, the laboratory must pay a fee 

to cover the cost of issuing a 

replacement certificate. The fee for a 

replacement certificate is based on the 

cost of issuing the replacement 

certificate to the laboratory. The fee 

must be paid in full before issuing the 

replacement certificate. 

■ 8. Effective January 27, 2024, 

§ 493.643 is revised to read as follows: 

§ 493.643 Additional fees applicable to 

laboratories issued a certificate of 

compliance. 

(a) Fee requirement. In addition to the 

fee required under § 493.638, a 

laboratory subject to routine inspections 

must pay a fee to cover the cost of 

determining program compliance. 

Laboratories issued a certificate for PPM 

procedures, certificate of waiver, or a 

certificate of accreditation are not 

subject to this fee for routine 

inspections. 

(b) Costs included in the fee. Included 

in the fee for determining program 

compliance are costs for evaluating 

qualifications of laboratory personnel; 

monitoring laboratory proficiency 

testing; and conducting onsite 

inspections of laboratories including: 

documenting deficiencies, evaluating 

laboratories’ plans to correct 

deficiencies, creating training programs, 

training surveyors, and necessary 

administrative costs. 

(c) Fee amount. The amount of the fee 

for determining program compliance is 

set biennially by HHS. 

(1) The fee is based on the category of 

test complexity and schedules or ranges 

of annual laboratory test volume and 

specialties tested, with the amounts of 


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the fees in each schedule being a 

function of the costs for all aspects of 

determining program compliance as set 

forth in § 493.638(c). 

(2) The fee is assessed and payable 

biennially. 

(3) The amount of the program 

compliance fee is the amount applicable 

to the laboratory listed in the most 

recent notice published in the Federal 

Register at the time that the fee is 

generated. 

(d) Additional fees. (1) If a laboratory 

issued a certificate of compliance has 

been inspected and follow-up visits are 

necessary because of identified 

deficiencies, HHS assesses the 

laboratory a fee to cover the cost of these 

visits. The fee is based on the actual 

resources and time necessary to perform 

the follow-up visits. HHS revokes the 

laboratory’s certificate of compliance for 

failure to pay the assessed fee. 

(2) If, after a certificate of compliance 

is issued, a laboratory adds services and 

requests that its certificate be upgraded, 

the laboratory must pay an additional 

fee if, to determine compliance with 

additional requirements, it is necessary 

to conduct an inspection, evaluate 

personnel, or monitor proficiency 

testing performance. The additional fee 

is based on the actual resources and 

time necessary to perform the activities. 

HHS revokes the laboratory’s certificate 

for failure to pay the compliance 

determination fee. 

(3) If it is necessary to conduct a 

complaint investigation, impose 

sanctions, or conduct a hearing, HHS 

assesses the laboratory holding a 

certificate of compliance a fee to cover 

the cost of these activities. If a 

complaint investigation results in a 

complaint being unsubstantiated, or if 

an HHS adverse action is overturned at 

the conclusion of the administrative 

appeals process, the Government’s costs 

of these activities are not imposed upon 

the laboratory. Costs for these activities 

are based on the actual resources and 

time necessary to perform the activities 

and are not assessed until after the 

laboratory concedes the existence of 

deficiencies or an ALJ rules in favor of 

HHS. HHS revokes the laboratory’s 

certificate of compliance for failure to 

pay the assessed costs. 

(4) Laboratories with a certificate of 

compliance must pay a fee if the 

laboratory fails to perform successfully 

in proficiency testing for one or more 

specialties, subspecialties, analytes, or 

tests specified in subpart I of this part, 

and it is necessary to conduct a desk 

review of the unsuccessful performance. 

The additional fee is based on the actual 

resources and time necessary to perform 

the desk review. HHS revokes the 

laboratory’s certificate of compliance for 

failure to pay the assessed costs. 

■ 9. Effective January 27, 2024, amend 

§ 493.645 by: 

■ a. Revising the section heading; 

■ b. Removing paragraph (a); 

■ c. Redesignating paragraphs (b) and 

(c) as paragraphs (a) and (b); 

■ d. Revising newly redesignated 

paragraph (a); and 

■ e. Adding a paragraph heading for 

newly redesignated paragraph (b). 

The revisions and addition read as 

follows: 

§ 493.645 Additional fees applicable to 

laboratories issued a certificate of 

accreditation, certificate of waiver, or 

certificate for PPM procedures. 

(a) Accredited laboratories. (1) A 

laboratory that is issued a certificate of 

accreditation is assessed an additional 

fee to cover the cost of performing 

validation inspections described at 

§ 493.563. All accredited laboratories 

share in the cost of these inspections. 

These costs are 5 percent of the same 

costs as those that are incurred when 

inspecting nonaccredited laboratories of 

the same schedule (or range) and are 

paid biennially by each accredited 

laboratory whether the accredited 

laboratory has a validation inspection or 

not. HHS revokes the laboratory’s 

certificate of accreditation for failure to 

pay the fee. 

(2) If a laboratory issued a certificate 

of accreditation has been inspected and 

follow-up visits are necessary because of 

identified deficiencies, HHS assesses 

the laboratory an additional fee to cover 

the cost of these visits. The fee is based 

on the actual resources and time 

necessary to perform the follow-up 

visits. HHS revokes the laboratory’s 

certificate of accreditation for failure to 

pay the fee. 

(b) Complaint surveys. * * * 

§ 493.646 [Removed] 

■ 10. Effective January 27, 2024, 

§ 493.646 is removed. 

■ 11. Effective January 27, 2024, 

§ 493.649 is revised to read as follows: 

§ 493.649 Additional fees applicable to 

approved State laboratory programs. 

(a) Approved State laboratory 

programs. State laboratory programs 

approved by HHS are assessed a fee for 

the following: 

(1) Costs of Federal inspections of 

laboratories in that State (that is, CLIAexempt laboratories) to verify that 

standards are being enforced in an 

appropriate manner. 

(2) Costs incurred for investigations of 

complaints against the State’s CLIAexempt laboratories if the complaint is 

substantiated. 

(3) The State’s pro rata share of 

general overhead to administer the 

laboratory certification program under 

section 353 of the PHS Act. 

(b) [Reserved] 

■ 12. Effective January 27, 2024, 

§ 493.655 is added to subpart F to read 

as follows: 

§ 493.655 Payment of fees. 

(a) Except for laboratories covered by 

approved State laboratory programs, all 

laboratories are notified in writing by 

HHS or its designee of the appropriate 

fee(s) and instructions for submitting 

the fee(s), including the due date for 

payment and where to make payment. 

The appropriate certificate is not issued 

until the applicable fees have been paid. 

(b) For approved State laboratory 

programs, HHS estimates the cost of 

conducting validation inspections as 

described at § 493.563 within the State 

on at least a biennial period. HHS or its 

designee notifies the State by mail of the 

appropriate fees, including the due date 

for payment and the address of the 

United States Department of Treasury 

designated commercial bank to which 

payment must be made. In addition, if 

complaint investigations are conducted 

in laboratories within these States and 

are substantiated, HHS bills the State(s) 

the costs of the complaint 

investigations. 

■ 13. Effective January 27, 2024, 

§ 493.680 is added to subpart F to read 

as follows: 

§ 493.680 Methodology for determining the 

biennial fee increase. 

(a) General rule. Except for fees 

assessed to State laboratory programs 

approved by HHS, the fee amounts 

described in this subpart are subject to 

a biennial increase based on a two-part 

calculation of the Consumer Price 

Index—Urban (CPI–U) inflation 

adjustment and, if applicable, an 

additional increase as follows: 

(1) CMS calculates the inflation rate 

using the compounded CPI–U over 2 

years and, provided that the calculated 

rate is greater than zero, applies an 

increase to all fee amounts equal to the 

calculated rate. 

(2) If the total fee amounts, including 

any increase applied under paragraph 

(a)(1) of this section, do not match or 

exceed actual program obligations based 

on a review of the previous 2 years’ 

obligations, CMS applies an additional 

across the board increase to each 

laboratory’s fees by calculating the 

difference between the total fee amounts 

and actual program obligations. 

(b) Baseline. Any increase applied 

under paragraph (a) of this section is 

incorporated into the baseline fee 


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90038 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

amounts for any subsequent biennial 

increase. 

(c) Publication. Any increase applied 

under paragraph (a) of this section, 

including the calculation thereof, will 

be published as a notice in the Federal 

Register. 

■ 14. Effective December 28, 2024, 

amend § 493.945 by revising paragraphs 

(b)(2), (b)(3)(i), (b)(3)(ii)(C) introductory 

text, and (b)(3)(ii)(F) introductory text to 

read as follows: 

§ 493.945 Cytology; gynecologic 

examinations. 

* * * * * 

(b) * * * 

(2) An individual qualified as a 

technical supervisor under 

§ 493.1449(b) or (e) who routinely 

interprets gynecologic slide 

preparations only after they have been 

examined by a cytotechnologist can 

either be tested using a test set that has 

been screened by a cytotechnologist in 

the same laboratory or using a test set 

that has not been screened. A technical 

supervisor who screens and interprets 

slide preparations that have not been 

previously examined must be tested 

using a test set that has not been 

previously screened. 

(3) * * * 

(i) Each slide set must contain 10 or 

20 slides with point values established 

for each slide preparation based on the 

significance of the relationship of the 

interpretation of the slide to a clinical 

condition and whether the participant 

in the testing event is a cytotechnologist 

qualified under § 493.1469 or § 493.1483 

or functioning as a technical supervisor 

in cytology qualified under 

§ 493.1449(b) or (e) of this part. 

(ii) * * * 

(C) Criteria for scoring system for a 

10-slide test set. (See table at paragraph 

(b)(3)(ii)(A) of this section for a 

description of the response categories.) 

For technical supervisors qualified 

under § 493.1449(b) or (e): 

* * * * * 

(F) Criteria for scoring system for a 20- 

slide test set. (See table at paragraph 

(b)(3)(ii)(A) of this section for a 

description of the response categories.) 

For technical supervisors qualified 

under § 493.1449(b) or (e): 

* * * * * 

■ 15. Effective December 28, 2024, 

amend § 493.1273 by revising paragraph 

(b) to read as follows: 

§ 493.1273 Standard: Histopathology. 

* * * * * 

(b) The laboratory must retain stained 

slides, specimen blocks, and tissue 

remnants as specified in § 493.1105. The 

remnants of tissue specimens must be 

maintained in a manner that ensures 

proper preservation of the tissue 

specimens until the portions submitted 

for microscopic examination have been 

examined and a diagnosis made by an 

individual qualified under 

§ 493.1449(b), (f), or (g). 

* * * * * 

■ 16. Effective December 28, 2024, 

amend § 493.1274 by revising paragraph 

(c)(1)(i)(A) to read as follows: 

§ 493.1274 Standard: Cytology. 

* * * * * 

(c) * * * 

(1) * * * 

(i) * * * 

(A) A technical supervisor qualified 

under § 493.1449(b) or (e). 

* * * * * 

■ 17. Effective December 28, 2024, 

§ 493.1278 is revised to read as follows: 

§ 493.1278 Standard: Histocompatibility. 

(a) General. The laboratory must meet 

the following requirements: 

(1) Use a continuous monitoring 

system and alert system to monitor the 

storage temperature of specimens (donor 

and recipient) and reagents and notify 

laboratory personnel when temperature 

limits are exceeded. 

(2) Establish and follow written 

policies and procedures for the storage 

and retention of specimens based on the 

specific type of specimen. All 

specimens must be easily retrievable. 

The laboratory must have an emergency 

plan for alternate storage. 

(3) If the laboratory uses immunologic 

reagents to facilitate or enhance the 

isolation or identification of 

lymphocytes or lymphocyte subsets, the 

efficacy of the methods must be 

monitored with appropriate quality 

control procedures. 

(4) Participate in at least one national 

or regional cell exchange program, if 

available, or develop an exchange 

system with another laboratory in order 

to validate interlaboratory 

reproducibility. 

(b) Human leukocyte antigen (HLA) 

typing. The laboratory must do the 

following: 

(1) Use HLA antigen terminology that 

conforms to the World Health 

Organization (WHO) Nomenclature 

Committee for Factors of the HLA 

System. 

(2) Have available and follow written 

criteria for determining when antigen 

and allele typing are required. 

(c) Antibody screening and 

identification. The laboratory must 

make a reasonable effort to have 

available monthly serum specimens for 

all potential transplant recipients for 

periodic antibody screening, 

identification, and crossmatch. 

(d) Crossmatching. For each type of 

crossmatch that a laboratory performs, 

the laboratory must do the following, as 

applicable: 

(1) Establish and follow written 

policies and procedures for performing 

a crossmatch. 

(2) Have available and follow written 

criteria for the following: 

(i) Defining donor and recipient HLA 

antigens, alleles, and antibodies to be 

tested; 

(ii) Defining the criteria necessary to 

assess a recipient’s alloantibody status; 

(iii) Assessing recipient antibody 

presence or absence on an ongoing 

basis; 

(iv) Typing the donor, to include 

those HLA antigens to which antibodies 

have been identified in the potential 

recipient, as applicable; 

(v) Describing the circumstances in 

which pre- and post-transplant 

confirmation testing of donor and 

recipient specimens is required; 

(vi) Making available all applicable 

donor and recipient test results to the 

transplant team; 

(vii) Ensuring immunologic 

assessments are based on test results 

obtained from a test report from a CLIAcertified laboratory; and 

(viii) Defining time limits between 

recipient testing and the performance of 

a crossmatch. 

(3) The test report must specify the 

type of crossmatch performed. 

(e) Transplantation. Laboratories 

performing histocompatibility testing 

for infusion and transplantation 

purposes must establish and follow 

written policies and procedures 

specifying the histocompatibility testing 

(that is, HLA typing, antibody screening 

and identification, and crossmatching) 

to be performed for each type of cell, 

tissue, or organ to be infused or 

transplanted. The laboratory’s policies 

and procedures must include, as 

applicable— 

(1) Testing protocols that address: 

(i) Transplant type (organ, tissue, 

cell); 

(ii) Donor (living, deceased, or 

paired): and 

(iii) Recipient (high risk vs. 

unsensitized); 

(2) Type and frequency of testing 

required to support clinical transplant 

protocols; and 

(3) Process to obtain a recipient 

specimen, if possible, for crossmatch 

that is collected on the day of the 

transplant and prior to transplantation. 

If the laboratory is unable to obtain a 

recipient specimen on the day of the 


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transplant, the laboratory must have a 

process to document its efforts to obtain 

the specimen. 

(f) Documentation. The laboratory 

must document all control procedures 

performed, as specified in this section. 

■ 18. Effective December 28, 2024, 

amend § 493.1359 by revising paragraph 

(b)(2) and adding paragraphs (c) and (d) 

to read as follows: 

§ 493.1359 Standard; PPM laboratory 

director responsibilities. 

* * * * * 

(b) * * * 

(2) Is performed in accordance with 

applicable requirements in this subpart 

and subparts H, J, and K of this part; 

(c) Evaluate the competency of all 

testing personnel and ensure that the 

staff maintains their competency to 

perform test procedures and report test 

results promptly, accurately, and 

proficiently. The procedures for 

evaluation of the competency of the staff 

must include, but are not limited to— 

(1) Direct observations of routine 

patient test performance, including, if 

applicable, specimen handling, 

processing, and testing; 

(2) Monitoring the recording and 

reporting of test results; 

(3) Review of test results or 

worksheets; 

(4) Assessment of test performance 

through testing internal blind testing 

samples or external proficiency testing 

samples; and 

(5) Assessment of problem solving 

skills; and 

(d) Evaluate and document the 

performance of individuals responsible 

for PPM testing at least semiannually 

during the first year the individual tests 

patient specimens. Thereafter, 

evaluations and documentation must be 

performed at least annually. 

■ 19. Effective December 28, 2024, 

amend § 493.1405 by revising paragraph 

(b) to read as follows: 

§ 493.1405 Standard; Laboratory director 

qualifications. 

* * * * * 

(b) The laboratory director must— 

(1)(i) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic or clinical 

pathology, or both, by the American 

Board of Pathology or the American 

Osteopathic Board of Pathology; or 

(2)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have had laboratory training or 

experience consisting of: 

(A) At least 1 year directing or 

supervising nonwaived laboratory 

testing; and 

(B) Have at least 20 CE credit hours 

in laboratory practice that cover the 

laboratory director responsibilities 

defined in § 493.1407; or 

(3)(i)(A) Hold an earned doctoral 

degree in a chemical, biological, clinical 

or medical laboratory science or medical 

technology from an accredited 

institution; or 

(B) Hold an earned doctoral degree; 

and 

(1) Have at least 16 semester hours of 

doctoral level coursework in biology, 

chemistry, medical technology (MT), 

clinical laboratory science (CLS), or 

medical laboratory science (MLS); or 

(2) An approved thesis or research 

project in biology/chemistry/MT/CLS/ 

MLS related to laboratory testing for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of the health of, human 

beings; and 

(ii) Have at least 20 CE credit hours 

in laboratory practice that cover the 

laboratory director responsibilities 

defined in § 493.1407; and 

(A) Be certified and continue to be 

certified by a board approved by HHS; 

and 

(B) Have had at least 1 year of 

experience directing or supervising 

nonwaived laboratory testing; or 

(4)(i)(A) Have earned a master’s 

degree in a chemical, biological, clinical 

or medical laboratory science or medical 

technology from an accredited 

institution; or 

(B)(1) Meet bachelor’s degree 

equivalency; and 

(2) Have at least 16 semester hours of 

additional graduate level coursework in 

biology, chemistry, medical technology, 

clinical or medical laboratory science; 

or 

(C)(1) Meet bachelor’s degree 

equivalency; and 

(2) Have at least 16 semester hours in 

a combination of graduate level 

coursework in biology, chemistry, 

medical technology, clinical or medical 

laboratory science and an approved 

thesis or research project related to 

laboratory testing for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

the health of, human beings; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in 

nonwaived testing; and 

(iii) Have at least 1 year of supervisory 

laboratory experience in nonwaived 

testing; and 

(iv) Have at least 20 CE credit hours 

in laboratory practice that cover the 

director responsibilities defined in 

§ 493.1407; or 

(5)(i)(A) Have earned a bachelor’s 

degree in a chemical, biological, clinical 

or medical laboratory science or medical 

technology from an accredited 

institution; or 

(B) At least 120 semester hours, or 

equivalent, from an accredited 

institution that, at a minimum, includes 

either— 

(1) Forty-eight (48) semester hours of 

medical laboratory science or medical 

laboratory technology courses; or 

(2) Forty-eight (48) semester hours of 

science courses that include— 

(i) Twelve (12) semester hours of 

chemistry, which must include general 

chemistry and biochemistry or organic 

chemistry; 

(ii) Twelve (12) semester hours of 

biology, which must include general 

biology and molecular biology, cell 

biology or genetics; and 

(iii) Twenty-four (24) semester hours 

of chemistry, biology, or medical 

laboratory science or medical laboratory 

technology in any combination; and 

(ii) Have at least 2 years of laboratory 

training or experience, or both, in 

nonwaived testing; and 

(iii) Have at least 2 years of 

supervisory laboratory experience in 

nonwaived testing; and 

(iv) Have at least 20 CE credit hours 

in laboratory practice that cover the 

director responsibilities defined in 

§ 493.1407. 

(6) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a laboratory 

director of moderate complexity testing 

under this section if they were qualified 

and serving as a laboratory director of 

moderate complexity testing in a CLIAcertified laboratory as of December 28, 

2024, and have done so continuously 

since December 28, 2024. 

§ 493.1406 [Removed] 

■ 20. Effective December 28, 2024, 

§ 493.1406 is removed. 

■ 21. Effective December 28, 2024, 

amend § 493.1407 by revising paragraph 

(c) to read as follows: 

§ 493.1407 Standard; Laboratory director 

responsibilities. 

* * * * * 

(c) The laboratory director must: 

(1) Be onsite at least once every 6 

months, with at least 4 months between 

the minimum two on-site visits. 

Laboratory directors may elect to be onsite more frequently and must continue 

to be accessible to the laboratory to 

provide telephone or electronic 

consultation as needed; and 

(2) Provide documentation of these 

visits, including evidence of performing 


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activities that are part of the laboratory 

director responsibilities. 

* * * * * 

■ 22. Effective December 28, 2024, 

amend § 493.1411 by revising paragraph 

(b) to read as follows: 

§ 493.1411 Standard; Technical consultant 

qualifications. 

* * * * * 

(b) The technical consultant must— 

(1)(i) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic or clinical 

pathology, or both, by the American 

Board of Pathology or the American 

Osteopathic Board of Pathology; or 

(2)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in 

nonwaived testing, in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible (for example, physicians 

certified either in hematology or 

hematology and medical oncology by 

the American Board of Internal 

Medicine are qualified to serve as the 

technical consultant in hematology); or 

(3)(i)(A) Hold an earned doctoral or 

master’s degree in a chemical, 

biological, clinical or medical laboratory 

science, or medical technology from an 

accredited institution; or 

(B) Meet either requirements in 

§ 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or 

(C); and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in 

nonwaived testing, in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible; or 

(4)(i)(A) Have earned a bachelor’s 

degree in a chemical, biological, clinical 

or medical laboratory science, or 

medical technology from an accredited 

institution; or 

(B) Meet § 493.1405(b)(5)(i)(B); and 

(ii) Have at least 2 years of laboratory 

training or experience, or both, in 

nonwaived testing, in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible; or 

(5)(i) Have earned an associate degree 

in medical laboratory technology, 

medical laboratory science, or clinical 

laboratory science; and 

(ii) Have at least 4 years of laboratory 

training or experience, or both, in 

nonwaived testing, in the designated 

specialty or subspecialty areas of service 

for which the technical consultant is 

responsible. 

(6) For blood gas analysis, the 

individual must— 

(i) Be qualified under paragraph 

(b)(1), (2), (3), or (4) of this section; or 

(ii)(A) Have earned a bachelor’s 

degree in respiratory therapy or 

cardiovascular technology from an 

accredited institution; and 

(B) Have at least 2 years of laboratory 

training or experience, or both, in blood 

gas analysis; or 

(7) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a technical 

consultant under this section if they 

were qualified and serving as a 

technical consultant for moderate 

complexity testing in a CLIA-certified 

laboratory as of December 28, 2024, and 

have done so continuously since 

December 28, 2024. 

Note 1 to paragraph (b): The technical 

consultant requirements for ‘‘laboratory 

training or experience, or both’’ in each 

specialty or subspecialty may be acquired 

concurrently in more than one of the 

specialties or subspecialties of service, 

excluding waived tests. For example, an 

individual who has a bachelor’s degree in 

biology and additionally has documentation 

of 2 years of work experience performing 

tests of moderate complexity in all specialties 

and subspecialties of service, would be 

qualified as a technical consultant in a 

laboratory performing moderate complexity 

testing in all specialties and subspecialties of 

service. 

■ 23. Effective December 28, 2024, 

amend § 493.1417 by revising paragraph 

(a) to read as follows: 

§ 493.1417 Standard; Clinical consultant 

qualifications. 

* * * * * 

(a) Be qualified as a laboratory 

director under § 493.1405(b)(1), (2), or 

(3); or 

* * * * * 

■ 24. Effective December 28, 2024, 

amend § 493.1423 by revising paragraph 

(b) to read as follows: 

§ 493.1423 Standard; Testing personnel 

qualifications. 

* * * * * 

(b) Meet one of the following 

requirements: 

(1) Be a doctor of medicine or doctor 

of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; or 

(2) Have earned a doctoral, master’s, 

or bachelor’s degree in a chemical, 

biological, clinical or medical laboratory 

science, or medical technology, or 

nursing from an accredited institution; 

or 

(3) Meet the requirements in 

§ 493.1405(b)(3)(i)(B), (b)(4)(i)(B) or (C), 

or (b)(5)(i)(B); or 

(4) Have earned an associate degree in 

a chemical, biological, clinical or 

medical laboratory science, or medical 

laboratory technology or nursing from 

an accredited institution; or 

(5) Be a high school graduate or 

equivalent and have successfully 

completed an official military medical 

laboratory procedures course of at least 

a duration of 50 weeks and have held 

the military enlisted occupational 

specialty of Medical Laboratory 

Specialist (Laboratory Technician); or 

(6)(i) Have earned a high school 

diploma or equivalent; and 

(ii) Have documentation of laboratory 

training appropriate for the testing 

performed prior to analyzing patient 

specimens. Such training must ensure 

that the individual has— 

(A) The skills required for proper 

specimen collection, including patient 

preparation, if applicable, labeling, 

handling, preservation or fixation, 

processing or preparation, 

transportation, and storage of 

specimens; 

(B) The skills required for 

implementing all standard laboratory 

procedures; 

(C) The skills required for performing 

each test method and for proper 

instrument use; 

(D) The skills required for performing 

preventive maintenance, 

troubleshooting, and calibration 

procedures related to each test 

performed; 

(E) A working knowledge of reagent 

stability and storage; 

(F) The skills required to implement 

the quality control policies and 

procedures of the laboratory; 

(G) An awareness of the factors that 

influence test results; and 

(H) The skills required to assess and 

verify the validity of patient test results 

through the evaluation of quality control 

sample values prior to reporting patient 

test results. 

(7) For blood gas analysis, the 

individual must— 

(i) Be qualified under paragraph 

(b)(1), (2), (3), or (4) of this section; or 

(ii)(A) Have earned a bachelor’s 

degree in respiratory therapy or 

cardiovascular technology from an 

accredited institution; and 

(B) Have at least 1 year of laboratory 

training or experience, or both, in blood 

gas analysis; or 

(iii)(A) Have earned an associate 

degree related to pulmonary function 

from an accredited institution; and 

(B) Have at least 2 years of laboratory 

training or experience, or both, in blood 

gas analysis. 


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(8) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a testing 

personnel under this section if they 

were qualified and serving as a testing 

personnel for moderate complexity 

testing in a CLIA-certified laboratory as 

of December 28, 2024, and have done so 

continuously since December 28, 2024. 

■ 25. Effective December 28, 2024, 

amend § 493.1443 by revising paragraph 

(b) to read as follows: 

§ 493.1443 Standard: Laboratory director 

qualifications. 

* * * * * 

(b) The laboratory director must— 

(1)(i) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic or clinical 

pathology, or both, by the American 

Board of Pathology or the American 

Osteopathic Board of Pathology; or 

(2)(i) Be a doctor of medicine, a doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have at least 2 years of experience 

directing or supervising high 

complexity testing; and 

(iii) Have at least 20 CE credit hours 

in laboratory practice that cover the 

director responsibilities defined in 

§ 493.1445; or 

(3)(i)(A) Hold an earned doctoral 

degree in a chemical, biological, clinical 

or medical laboratory science or medical 

technology from an accredited 

institution; or 

(B) Hold an earned doctoral degree; 

and 

(1) Have at least 16 semester hours of 

doctoral level coursework in biology, 

chemistry, medical technology (MT), 

clinical laboratory science (CLS), or 

medical laboratory science (MLS); or 

(2) An approved thesis or research 

project in biology/chemistry/MT/CLS/ 

MLS related to laboratory testing for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of the health of, human 

beings; and 

(ii) Be certified and continue to be 

certified by a board approved by HHS; 

and 

(iii) Have at least 2 years of: 

(A) Laboratory training or experience, 

or both: and 

(B) Laboratory experience directing or 

supervising high complexity testing; 

and 

(iv) Have at least 20 CE credit hours 

in laboratory practice that cover the 

director responsibilities defined in 

§ 493.1445; or 

(4) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a laboratory 

director of high complexity testing 

under this section if they were qualified 

and serving as a laboratory director of 

high complexity testing in a CLIAcertified laboratory as of December 28, 

2024, and have done so continuously 

since December 28, 2024. 

(5) For the subspecialty of oral 

pathology, be certified by the American 

Board of Oral Pathology, American 

Board of Pathology, or the American 

Osteopathic Board of Pathology. 

■ 26. Effective December 28, 2024, 

amend § 493.1445 by revising 

paragraphs (c) and (e)(10) to read as 

follows: 

§ 493.1445 Standard; Laboratory director 

responsibilities. 

* * * * * 

(c) The laboratory director must: 

(1) Be onsite at least once every 6 

months, with at least 4 months between 

the minimum two on-site visits. 

Laboratory directors may elect to be onsite more frequently and must continue 

to be accessible to the laboratory to 

provide telephone or electronic 

consultation as needed; and 

(2) Provide documentation of these 

visits, including evidence of performing 

activities that are part of the laboratory 

director responsibilities. 

* * * * * 

(e) * * * 

(10) Ensure that a general supervisor 

provides on-site supervision of high 

complexity test performance by testing 

personnel qualified under 

§ 493.1489(b)(5); 

* * * * * 

■ 27. Effective December 28, 2024, 

§ 493.1449 is revised to read as follows: 

§ 493.1449 Standard; Technical supervisor 

qualifications. 

The laboratory must employ one or 

more individuals who are qualified by 

education and either training or 

experience to provide technical 

supervision for each of the specialties 

and subspecialties of service in which 

the laboratory performs high complexity 

tests or procedures. The director of a 

laboratory performing high complexity 

testing may function as the technical 

supervisor provided he or she meets the 

qualifications specified in this section. 

(a) The technical supervisor must 

possess a current license issued by the 

State in which the laboratory is located, 

if such licensing is required; and 

(b) The laboratory may perform 

anatomic and clinical laboratory 

procedures and tests in all specialties 

and subspecialties of services except 

histocompatibility and clinical 

cytogenetics services provided the 

individual functioning as the technical 

supervisor— 

(1) Is a doctor of medicine or doctor 

of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(2) Is certified in both anatomic and 

clinical pathology by the American 

Board of Pathology or the American 

Osteopathic Board of Pathology. 

(c) Bacteriology, Mycobacteriology, 

Mycology, Parasitology or Virology—If 

the requirements of paragraph (b) of this 

section are not met and the laboratory 

performs tests in the subspecialty of 

bacteriology, mycobacteriology, 

mycology, parasitology, or virology, the 

individual functioning as the technical 

supervisor must— 

(1)(i) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in clinical pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing within the specialty 

of microbiology with a minimum of 6 

months of experience in high 

complexity testing within the applicable 

microbiology subspecialty; or 

(3)(i)(A) Have an earned doctoral 

degree in a chemical, biological, clinical 

or medical laboratory science, or 

medical technology from an accredited 

institution; or 

(B) Meet the requirements in 

§ 493.1443(b)(3)(i)(B); and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing within the specialty 

of microbiology with a minimum of 6 

months of experience in high 

complexity testing within the applicable 

subspecialty; or 

(4)(i)(A) Have earned a master’s 

degree in a chemical, biological, clinical 

or medical laboratory science, or 

medical technology from an accredited 

institution; or 

(B)(1) Meet bachelor’s degree 

equivalency; and 

(2) Have at least 16 semester hours of 

additional graduate level coursework in 

chemical, biological, clinical or medical 

laboratory science, or medical 

technology; or 


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90042 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

(C)(1) Meet bachelor’s degree 

equivalency; and 

(2) Have at least 16 semester hours in 

a combination of graduate level 

coursework in biology, chemistry, 

medical technology, or clinical or 

medical laboratory science and an 

approved thesis or research project 

related to laboratory testing for the 

diagnosis, prevention, or treatment of 

any disease or impairment of, or the 

assessment of the health of, human 

beings; and 

(ii) Have at least 2 years of laboratory 

training or experience, or both, in high 

complexity testing within the specialty 

of microbiology with a minimum of 6 

months of experience in high 

complexity testing within the applicable 

subspecialty; or 

(5)(i)(A) Have earned a bachelor’s 

degree in a chemical, biological, clinical 

or medical laboratory science, or 

medical technology from an accredited 

institution; or 

(B) Have at least 120 semester hours, 

or equivalent, from an accredited 

institution that, at a minimum, includes 

either— 

(1) Forty-eight (48) semester hours of 

medical laboratory technology courses; 

or 

(2) Forty-eight (48) semester hours of 

science courses that include— 

(i) Twelve (12) semester hours of 

chemistry, which must include general 

chemistry and biochemistry or organic 

chemistry; 

(ii) Twelve (12) semester hours of 

biology, which must include general 

biology and molecular biology, cell 

biology or genetics; and 

(iii) Twenty-four (24) semester hours 

of chemistry, biology, or medical 

laboratory science or technology in any 

combination; and 

(ii) Have at least 4 years of laboratory 

training or experience, or both, in high 

complexity testing within the specialty 

of microbiology with a minimum of 6 

months of experience in high 

complexity testing within the applicable 

subspecialty. 

(d) Diagnostic Immunology, 

Chemistry, Hematology, Radiobioassay, 

or Immunohematology—If the 

requirements of paragraph (b) of this 

section are not met and the laboratory 

performs tests in the specialty of 

diagnostic immunology, chemistry, 

hematology, radiobioassay, or 

immunohematology, the individual 

functioning as the technical supervisor 

must— 

(1)(i) Be a doctor of medicine or a 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in clinical pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing for the applicable 

specialty; or 

(3)(i)(A) Have an earned doctoral 

degree in a chemical, biological, clinical 

or medical laboratory science, or 

medical technology from an accredited 

institution; or 

(B) Meet the education requirement at 

§ 493.1443(b)(3)(i)(B); and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing within the applicable 

specialty; or 

(4)(i)(A) Have earned a master’s 

degree in a chemical, biological, clinical 

or medical laboratory science, or 

medical technology from an accredited 

institution; or 

(B) Meet the education requirement at 

paragraph (c)(4)(i)(B) or (C) of this 

section; and 

(ii) Have at least 2 years of laboratory 

training or experience, or both, in high 

complexity testing for the applicable 

specialty; or 

(5)(i)(A) Have earned a bachelor’s 

degree in a chemical, biological, clinical 

or medical laboratory science, or 

medical technology from an accredited 

institution; or 

(B) Meet the education requirement at 

paragraph (c)(5)(i)(B) of this section; and 

(ii) Have at least 4 years of laboratory 

training or experience, or both, in high 

complexity testing for the applicable 

specialty. 

(e) Cytology—If the requirements of 

paragraph (b) of this section are not met 

and the laboratory performs tests in the 

subspecialty of cytology, the individual 

functioning as the technical supervisor 

must— 

(1)(i) Be a doctor of medicine or a 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2) An individual qualified under 

paragraph (b) or (e)(1) of this section 

may delegate some of the cytology 

technical supervisor responsibilities to 

an individual who is in the final year of 

full-time training leading to certification 

specified in paragraph (b) or (e)(1)(ii) of 

this section provided the technical 

supervisor qualified under paragraph (b) 

or (e)(1) of this section remains 

ultimately responsible for ensuring that 

all of the responsibilities of the cytology 

technical supervisor are met. 

(f) Histopathology—If the 

requirements of paragraph (b) of this 

section are not met and the laboratory 

performs tests in the subspecialty of 

histopathology, the individual 

functioning as the technical supervisor 

must— 

(1) Meet one of the following 

requirements: 

(i)(A) Be a doctor of medicine or a 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(B) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(ii) An individual qualified under 

paragraph (b) of this section or this 

paragraph (f)(1) may delegate to an 

individual who is a resident in a 

training program leading to certification 

specified in paragraph (b) or (f)(1)(i)(B) 

of this section, the responsibility for 

examination and interpretation of 

histopathology specimens. 

(2) For tests in dermatopathology, 

meet one of the following requirements: 

(i)(A) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(B) Meet one of the following 

requirements: 

(1) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2) Be certified in dermatopathology 

by the American Board of Dermatology 

and the American Board of Pathology; 

or 

(3) Be certified in dermatology by the 

American Board of Dermatology; or 

(ii) An individual qualified under 

paragraph (b) or (f)(2)(i) of this section 

may delegate to an individual who is a 

resident in a training program leading to 

certification specified in paragraph (b) 

or (f)(2)(i)(B) of this section, the 

responsibility for examination and 

interpretation of dermatopathology 

specimens. 

(3) For tests in ophthalmic pathology, 

meet one of the following requirements: 

(i)(A) Be a doctor of medicine or 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(B) Must meet one of the following 

requirements: 

(1) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 


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Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 90043 

(2) Be certified by the American Board 

of Ophthalmology and have successfully 

completed at least 1 year of formal postresidency fellowship training in 

ophthalmic pathology; or 

(ii) An individual qualified under 

paragraph (b) or (f)(3)(i) of this section 

may delegate to an individual who is a 

resident in a training program leading to 

certification specified in paragraph (b) 

or (f)(3)(i)(B) of this section, the 

responsibility for examination and 

interpretation of ophthalmic specimens; 

or 

(g) Oral Pathology—If the 

requirements of paragraph (b) of this 

section are not met and the laboratory 

performs tests in the subspecialty of oral 

pathology, the individual functioning as 

the technical supervisor must meet one 

of the following requirements: 

(1)(i) Be a doctor of medicine or a 

doctor of osteopathy licensed to practice 

medicine or osteopathy in the State in 

which the laboratory is located; and 

(ii) Be certified in anatomic pathology 

by the American Board of Pathology or 

the American Osteopathic Board of 

Pathology; or 

(2) Be certified in oral pathology by 

the American Board of Oral Pathology; 

or 

(3) An individual qualified under 

paragraph (b) or (g)(1) or (2) of this 

section may delegate to an individual 

who is a resident in a training program 

leading to certification specified in 

paragraph (b) or (g)(1) or (2) of this 

section, the responsibility for 

examination and interpretation of oral 

pathology specimens. 

(h) Histocompatibility—If the 

laboratory performs tests in the 

specialty of histocompatibility, the 

individual functioning as the technical 

supervisor must either— 

(1)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have training or experience that 

meets one of the following 

requirements: 

(A) Have 4 years of laboratory training 

or experience, or both, within the 

specialty of histocompatibility; or 

(B)(1) Have 2 years of laboratory 

training or experience, or both, in the 

specialty of general immunology; and 

(2) Have 2 years of laboratory training 

or experience, or both, in the specialty 

of histocompatibility; or 

(2)(i) Have an earned doctoral degree 

in a biological, clinical or medical 

laboratory science, or medical 

technology from an accredited 

institution; or meet the education 

requirement at § 493.1443(b)(3)(i)(B); 

and 

(ii) Have training or experience that 

meets one of the following 

requirements: 

(A) Have 4 years of laboratory training 

or experience, or both, within the 

specialty of histocompatibility; or 

(B)(1) Have 2 years of laboratory 

training or experience, or both, in the 

specialty of general immunology; and 

(2) Have 2 years of laboratory training 

or experience, or both, in the specialty 

of histocompatibility. 

(i) Clinical cytogenetics—If the 

laboratory performs tests in the 

specialty of clinical cytogenetics, the 

individual functioning as the technical 

supervisor must— 

(1)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; and 

(ii) Have 4 years of laboratory training 

or experience, or both, in genetics, 2 of 

which have been in clinical 

cytogenetics; or 

(2)(i) Hold an earned doctoral degree 

in a biological science, including 

biochemistry, clinical or medical 

laboratory science, or medical 

technology from an accredited 

institution; or meet the education 

requirement at § 493.1443(b)(3)(i)(B); 

and 

(ii) Have 4 years of laboratory training 

or experience, or both, in genetics, 2 of 

which have been in clinical 

cytogenetics. 

(j) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a technical 

supervisor under this section if they 

were qualified and serving as a 

technical supervisor for high complexity 

testing in a CLIA-certified laboratory as 

of December 28, 2024, and have done so 

continuously since December 28, 2024. 

Note 1 to paragraphs (b) through (i): The 

technical supervisor requirements for 

‘‘laboratory training or experience, or both’’ 

in each specialty or subspecialty may be 

acquired concurrently in more than one of 

the specialties or subspecialties of service. 

For example, an individual, who has a 

doctoral degree in chemistry and additionally 

has documentation of 1 year of laboratory 

experience working concurrently in high 

complexity testing in the specialties of 

microbiology and chemistry and 6 months of 

that work experience included high 

complexity testing in bacteriology, mycology, 

and mycobacteriology, would qualify as the 

technical supervisor for the specialty of 

chemistry and the subspecialties of 

bacteriology, mycology, and 

mycobacteriology. 

■ 28. Effective December 28, 2024, 

amend § 493.1451 by revising paragraph 

(c) introductory text to read as follows: 

§ 493.1451 Standard: Technical supervisor 

responsibilities. 

* * * * * 

(c) In cytology, the technical 

supervisor or the individual qualified 

under § 493.1449(e)(2)— 

* * * * * 

■ 29. Effective December 28, 2024, 

amend § 493.1455 by revising paragraph 

(a) to read as follows: 

§ 493.1455 Standard: Clinical consultant 

qualifications. 

* * * * * 

(a) Be qualified as a laboratory 

director under § 493.1443(b)(1), (2), or 

(3) or, for the subspecialty of oral 

pathology, § 493.1443(b)(5); 

* * * * * 

■ 30. Effective December 28, 2024, 

amend § 493.1461 by revising 

paragraphs (c), (d)(3)(i), and (e) to read 

as follows: 

§ 493.1461 Standard: General supervisor 

qualifications. 

* * * * * 

(c) If the requirements of paragraph 

(b)(1) or (2) of this section are not met, 

the individual functioning as the 

general supervisor must— 

(1)(i) Be a doctor of medicine, doctor 

of osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located or have 

earned a doctoral, master’s, or 

bachelor’s degree in a chemical, 

biological, clinical or medical laboratory 

science, or medical technology from an 

accredited institution; and 

(ii) Have at least 1 year of laboratory 

training or experience, or both, in high 

complexity testing; or 

(2)(i) Qualify as testing personnel 

under § 493.1489(b)(3); and 

(ii) Have at least 2 years of laboratory 

training or experience, or both, in high 

complexity testing; or 

(3) Meet the requirements at 

§ 493.1443(b)(3) or § 493.1449(c)(4) or 

(5); or 

(4) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a general 

supervisor under this section if they 

were qualified and serving as a general 

supervisor in a CLIA-certified laboratory 

as of December 28, 2024, and have done 

so continuously since December 28, 

2024. 

(d) * * * 


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90044 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Rules and Regulations 

(3)(i) Have earned an associate degree 

related to pulmonary function from an 

accredited institution; and 

* * * * * 

(e) * * * 

(1) In histopathology, by an 

individual who is qualified as a 

technical supervisor under 

§ 493.1449(b) or (f)(1); 

(2) In dermatopathology, by an 

individual who is qualified as a 

technical supervisor under 

§ 493.1449(b) or (f)(2); 

(3) In ophthalmic pathology, by an 

individual who is qualified as a 

technical supervisor under 

§ 493.1449(b) or (f)(3); and 

(4) In oral pathology, by an individual 

who is qualified as a technical 

supervisor under § 493.1449(b) or (g). 

§ 493.1462 [Removed] 

■ 31. Effective December 28, 2024, 

§ 493.1462 is removed. 

■ 32. Effective December 28, 2024, 

amend § 493.1463 by revising paragraph 

(b)(4) to read as follows: 

§ 493.1463 Standard: General supervisor 

responsibilities. 

* * * * * 

(b) * * * 

(4) Evaluating and documenting the 

competency of all testing personnel. 

* * * * * 

■ 33. Effective December 28, 2024, 

amend § 493.1469 by revising paragraph 

(a) to read as follows: 

§ 493.1469 Standard: Cytology general 

supervisor qualifications. 

* * * * * 

(a) Be qualified as a technical 

supervisor under § 493.1449(b) or (e); or 

* * * * * 

■ 34. Amend § 493.1483 by revising the 

introductory text and paragraph (b) to 

read as follows: 

§ 493.1483 Standard: Cytotechnologist 

qualifications. 

Each person examining cytology slide 

preparations must meet the 

qualifications of § 493.1449 (b) or (e), 

or— 

* * * * * 

(b) Meet one of the following 

requirements: 

(1) Have graduated from a school of 

cytotechnology accredited by the 

Commission on Accreditation of Allied 

Health Education Programs (CAAHEP); 

or 

(2) Be certified in cytotechnology by 

a certifying agency approved by HHS; or 

(3) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a 

cytotechnologist under this section if 

they were qualified and serving as a 

cytotechnologist in a CLIA-certified 

laboratory as of [effective date of the 

final rule], and have done so 

continuously since December 28, 2024. 

■ 35. Effective December 28, 2024, 

amend § 493.1489 by revising paragraph 

(b) to read as follows: 

§ 493.1489 Standard; Testing personnel 

qualifications. 

* * * * * 

(b) Meet one of the following 

requirements: 

(1) Be a doctor of medicine, doctor of 

osteopathy, or doctor of podiatric 

medicine licensed to practice medicine, 

osteopathy, or podiatry in the State in 

which the laboratory is located; or 

(2)(i) Have earned a doctoral, master’s, 

or bachelor’s degree in a chemical, 

biological, clinical or medical laboratory 

science, or medical technology from an 

accredited institution; 

(ii) Be qualified under the 

requirements of § 493.1443(b)(3) or 

§ 493.1449(c)(4) or (5); or 

(3)(i) Have earned an associate degree 

in a laboratory science or medical 

laboratory technology from an 

accredited institution or— 

(ii) Have education and training 

equivalent to that specified in paragraph 

(b)(2)(i) of this section that includes— 

(A) At least 60 semester hours, or 

equivalent, from an accredited 

institution that, at a minimum, includes 

either— 

(1) Twenty-four (24) semester hours of 

medical laboratory technology courses; 

or 

(2) Twenty-four (24) semester hours of 

science courses that include— 

(i) Six (6) semester hours of chemistry; 

(ii) Six (6) semester hours of biology; 

and 

(iii) Twelve (12) semester hours of 

chemistry, biology, or medical 

laboratory technology in any 

combination; and 

(B) Have laboratory training that 

includes: 

(1) Completion of a clinical laboratory 

training program approved or accredited 

by the ABHES or the CAAHEP (this 

training may be included in the 60 

semester hours listed in paragraph 

(b)(3)(ii)(A) of this section); or 

(2) At least 3 months documented 

laboratory training in each specialty in 

which the individual performs high 

complexity testing; or 

(4) Successful completion of an 

official U.S. military medical laboratory 

procedures training course of at least 50 

weeks duration and having held the 

military enlisted occupational specialty 

of Medical Laboratory Specialist 

(Laboratory Technician); or 

(5) Notwithstanding any other 

provision of this section, an individual 

is considered qualified as a high 

complexity testing personnel under this 

section if they were qualified and 

serving as a high complexity testing 

personnel in a CLIA-certified laboratory 

as of December 28, 2024, and have done 

so continuously since December 28, 

2024. 

(6) For blood gas analysis— 

(i) Be qualified under paragraph 

(b)(1), (2), (3), (4), or (5) of this section; 

or 

(ii) Have earned a bachelor’s degree in 

respiratory therapy or cardiovascular 

technology from an accredited 

institution; or 

(iii) Have earned an associate degree 

related to pulmonary function from an 

accredited institution. 

(7) For histopathology, meet the 

qualifications of § 493.1449(b) or (f) to 

perform tissue examinations. 

§ 493.1491 [Removed] 

■ 36. Effective December 28, 2024, 

§ 493.1491 is removed. 

■ 37. Effective December 28, 2024, 

amend § 493.1804 by revising paragraph 

(c)(1) to read as follows: 

§ 493.1804 General considerations. 

* * * * * 

(c) * * * 

(1) CMS may impose alternative 

sanctions in lieu of, or in addition to, 

principal sanctions. 

* * * * * 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2023–28170 Filed 12–22–23; 4:15 pm] 

BILLING CODE 4120–01–P 


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